ESSURE
Report
- Report Number
- 2951250-2017-04640
- Event Type
- Injury
- Date Received
- October 12, 2017
- Date of Event
- March 1, 2012
- Report Date
- May 27, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PERFORATION/ PERFORATION (FALLOPIAN TUBE DIAGNOSIS: (S))"), DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE/ MIGRATION OF ESSURE DEVICE- LOCATION OF DEVICE: UNKNOWN/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS") AND AUTOIMMUNE DISORDER ("AUTO-IMMUNE REACTION/ AUTOIMMUNE DISORDER") IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 927086, 901333) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA IUD. CONCURRENT CONDITIONS INCLUDED C-SECTION, MORBID OBESITY, IRRITABLE BOWEL SYNDROME SINCE 2007, DIABETES SINCE 2001, HYPERTENSION SINCE 2008, HYPOTHYROIDISM SINCE 2003, PSORIATIC ARTHRITIS SINCE 2000, ARTHRITIS SINCE 2015 AND CIRRHOSIS LIVER SINCE 2015. CONCOMITANT PRODUCTS INCLUDED LEVONORGESTREL (MIRENA)(B)(6)2011 TO FEBRUARY 2013 FOR CONTRACEPTION AS WELL AS PARACETAMOL (ACETAMINOPHEN). ON(B)(6)2012, THE PATIENT HAD ESSURE INSERTED. IN MARCH 2012, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("SEVERE PELVIC PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS - CONDITION: DEPRESSION") AND ANXIETY ("MENTAL ANGUISH / PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS - CONDITION: ANXIETY"). IN APRIL 2012, THE PATIENT EXPERIENCED AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION"). ON (B)(6)2016, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("LEFT LOWER QUADRANT PAIN"), 4 YEARS 3 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), COMPLICATION OF DEVICE INSERTION ("COMPLICATION OF DEVICE INSERTION"), BACK PAIN ("LOWER BACK PAIN") AND ABDOMINAL PAIN ("ABDOMINAL AREA PAIN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). THE PATIENT WAS TREATED WITH ADALIMUMAB (HUMIRA), GLIBENCLAMIDE (GLYBURIDE), LEVOTHYROXINE SODIUM (SYNTHROID), LOSARTAN POTASSIUM (COZAAR), NIFEDIPINE, OMEPRAZOLE (PRILOSEC), RANITIDINE HYDROCHLORIDE (ZANTAC), VENLAFAXINE HYDROCHLORIDE (EFFEXOR) AND SURGERY (HYSTERECTOMY (PARTIAL), DIAGNOSTIC LAPAROSCOPY, BILATERAL SALPINGECTOMY WITH REMOVAL OF ESSURE COILS). ESSURE WAS REMOVED ON (B)(6)2016. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE EXPULSION, AUTOIMMUNE DISORDER, MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, MENORRHAGIA, HYPERSENSITIVITY, COMPLICATION OF DEVICE INSERTION, DYSMENORRHOEA, DEPRESSION, ANXIETY, WEIGHT INCREASED, BACK PAIN AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN AND THE PELVIC PAIN AND ABDOMINAL PAIN LOWER WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANXIETY, AUTOIMMUNE DISORDER, BACK PAIN, COMPLICATION OF DEVICE INSERTION, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, FALLOPIAN TUBE PERFORATION, HYPERSENSITIVITY, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE DID NOT WORSENED A PREVIOUSLY EXISTING INJURY/CONDITION. SHE WAS ADVISED OF (UNSPECIFIED) COMPLICATIONS OR PROBLEMS THAT OCCURRED AT THE TIME OF ESSURE PLACEMENT PROCEDURE. SHE DID NOT RETAIN THE ESSURE DEVICE OR ANY PORTION OF IT. SHE DID NOT HAD ANY COMPLICATIONS FROM ESSURE REMOVAL PROCEDURE. ESSURE DID NOT CAUSED BIRTH DEFECTS. THE PROXIMAL TIP OF THE ESSURE COIL WAS ACTUALLY POKING SUPERIORLY TO THE TUBE, ONCE THE TUBE HAD BEEN REMOVED, THE COIL WAS ENCASED ENTIRELY WITHIN THIS, LEFT CORNUAL REGION OF THE UTERUS WAS HEMOSTATIC AND WAS ABLE TO BE CAUTERIZED AS TAKING THE BITE IN THIS AREA ACTUALLY REMOVED THE COIL IN ITS ENTIRETY. IT WAS REPORTED THAT SHE HAD ESSURE DONE BUT SHE KNOCKED OUT AND RECOVERY WAS EASY PEASY LEMON SQUEEZY. CURRENT WEIGHT 250 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 40 KG/SQM. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WERE DESCRIBED/CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN. LOT NUMBER: 901333 MANUFACTURE DATE: 2011/09 EXPIRATION DATE: 2014/09 LOT NUMBER: 927086 MANUFACTURE DATE: 2011/12 EXPIRATION DATE: 2014/12 QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2018: PFS RECEIVED: EVENTS:WEIGHT GAIN, LOWER BACK PAIN, ABDOMINAL PAIN WERE ADDED. TREATMENT DRUGS AND CONCOMITANT CONDITIONS WERE ADDED. EVENT PT OF DEVICE DISLOCATION WAS UPDATED TO DEVICE EXPULSION. ON (B)(6)2018: PFS RECEIVED: TREATMENT DRUGS AND CONCOMITANT CONDITIONS ADDED. INCIDENT WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PERFORATION/ PERFORATION (FALLOPIAN TUBE DIAGNOSIS: (S))"), DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE") AND AUTOIMMUNE DISORDER ("AUTO-IMMUNE REACTION/ AUTOIMMUNE DISORDER") IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 927086, 901333) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA IUD. CONCURRENT CONDITIONS INCLUDED C-SECTION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION"). IN 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2016, 4 YEARS 3 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("LEFT LOWER QUADRANT PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("SEVERE PELVIC PAIN"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES") AND COMPLICATION OF DEVICE INSERTION ("COMPLICATION OF DEVICE INSERTION"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL), DIAGNOSTIC LAPAROSCOPY, BILATERAL SALPINGECTOMY WITH REMOVAL OF ESSURE COILS). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE DISLOCATION, AUTOIMMUNE DISORDER, MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, MENORRHAGIA, HYPERSENSITIVITY, COMPLICATION OF DEVICE INSERTION AND DYSMENORRHOEA OUTCOME WAS UNKNOWN AND THE PELVIC PAIN AND ABDOMINAL PAIN LOWER WAS RESOLVING. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR COMPLICATION OF DEVICE INSERTION WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, AUTOIMMUNE DISORDER, DEVICE DISLOCATION, DYSMENORRHOEA, FALLOPIAN TUBE PERFORATION, HYPERSENSITIVITY, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE DID NOT WORSENED A PREVIOUSLY EXISTING INJURY/CONDITION. SHE WAS ADVISED OF (UNSPECIFIED) COMPLICATIONS OR PROBLEMS THAT OCCURRED AT THE TIME OF ESSURE PLACEMENT PROCEDURE. SHE DID NOT RETAIN THE ESSURE DEVICE OR ANY PORTION OF IT. SHE DID NOT HAD ANY COMPLICATIONS FROM ESSURE REMOVAL PROCEDURE. ESSURE DID NOT CAUSED BIRTH DEFECTS. THE PROXIMAL TIP OF THE ESSURE COIL WAS ACTUALLY POKING SUPERIORLY TO THE TUBE, ONCE THE TUBE HAD BEEN REMOVED, THE COIL WAS ENCASED ENTIRELY WITHIN THIS, LEFT CORNUAL REGION OF THE UTERUS WAS HEMOSTATIC AND WAS ABLE TO BE CAUTERIZED AS TAKING THE BITE IN THIS AREA ACTUALLY REMOVED THE COIL IN ITS ENTIRETY. DIAGNOSTIC RESULTS: HYSTEROSALPINGOGRAM (HSG) ON (B)(6) 2013, ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED, TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WERE DESCRIBED/CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-MAY-2018: PLAINTIFF FACT SHEET RECEIVED: EVENTS MIGRATION OF ESSURE DEVICE, DYSMENORRHEA (CRAMPING) ADDED. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PERFORATION/ PERFORATION (FALLOPIAN TUBE DIAGNOSIS: (S))"), DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE") AND AUTOIMMUNE DISORDER ("AUTO-IMMUNE REACTION/ AUTOIMMUNE DISORDER") IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 927086, 901333) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA IUD. CONCURRENT CONDITIONS INCLUDED C-SECTION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION"). IN 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2016, 4 YEARS 3 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("LEFT LOWER QUADRANT PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("SEVERE PELVIC PAIN"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES") AND COMPLICATION OF DEVICE INSERTION ("COMPLICATION OF DEVICE INSERTION"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL), DIAGNOSTIC LAPAROSCOPY, BILATERAL SALPINGECTOMY WITH REMOVAL OF ESSURE COILS). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE DISLOCATION, AUTOIMMUNE DISORDER, MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, MENORRHAGIA, HYPERSENSITIVITY, COMPLICATION OF DEVICE INSERTION AND DYSMENORRHOEA OUTCOME WAS UNKNOWN AND THE PELVIC PAIN AND ABDOMINAL PAIN LOWER WAS RESOLVING. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR COMPLICATION OF DEVICE INSERTION WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, AUTOIMMUNE DISORDER, DEVICE DISLOCATION, DYSMENORRHOEA, FALLOPIAN TUBE PERFORATION, HYPERSENSITIVITY, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE DID NOT WORSENED A PREVIOUSLY EXISTING INJURY/CONDITION. SHE WAS ADVISED OF (UNSPECIFIED) COMPLICATIONS OR PROBLEMS THAT OCCURRED AT THE TIME OF ESSURE PLACEMENT PROCEDURE. SHE DID NOT RETAIN THE ESSURE DEVICE OR ANY PORTION OF IT. SHE DID NOT HAD ANY COMPLICATIONS FROM ESSURE REMOVAL PROCEDURE. ESSURE DID NOT CAUSED BIRTH DEFECTS. THE PROXIMAL TIP OF THE ESSURE COIL WAS ACTUALLY POKING SUPERIORLY TO THE TUBE, ONCE THE TUBE HAD BEEN REMOVED, THE COIL WAS ENCASED ENTIRELY WITHIN THIS, LEFT CORNUAL REGION OF THE UTERUS WAS HEMOSTATIC AND WAS ABLE TO BE CAUTERIZED AS TAKING THE BITE IN THIS AREA ACTUALLY REMOVED THE COIL IN ITS ENTIRETY. IT WAS REPORTED THAT SHE HAD ESSURE DONE BUT SHE KNOCKED OUT AND RECOVERY WAS EASY PEASY LEMON SQUEEZY. DIAGNOSTIC RESULTS: HYSTEROSALPINGOGRAM (HSG) ON (B)(6) 2013, ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED, TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WERE DESCRIBED/CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN. LOT NUMBER: 901333, MANUFACTURE DATE: 2011/09, EXPIRATION DATE: 2014/09. LOT NUMBER: 927086, MANUFACTURE DATE: 2011/12, EXPIRATION DATE: 2014/12. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-AUG-2018: QUALITY-SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT ). INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
CUTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PERFORATION/ PERFORATION (FALLOPIAN TUBE DIAGNOSIS: (S))"), DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE/ MIGRATION OF ESSURE DEVICE- LOCATION OF DEVICE: UNKNOWN") AND AUTOIMMUNE DISORDER ("AUTO-IMMUNE REACTION/ AUTOIMMUNE DISORDER") IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 927086, 901333) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA IUD. CONCURRENT CONDITIONS INCLUDED C-SECTION. CONCOMITANT PRODUCTS INCLUDED PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("SEVERE PELVIC PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). IN (B)(6) 2012, THE PATIENT EXPERIENCED AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION"). ON (B)(6) 2016, 4 YEARS 3 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("LEFT LOWER QUADRANT PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("MENSTRUATION ISSUES") AND COMPLICATION OF DEVICE INSERTION ("COMPLICATION OF DEVICE INSERTION"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL), DIAGNOSTIC LAPAROSCOPY, BILATERAL SALPINGECTOMY WITH REMOVAL OF ESSURE COILS). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE DISLOCATION, AUTOIMMUNE DISORDER, MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, MENORRHAGIA, HYPERSENSITIVITY, COMPLICATION OF DEVICE INSERTION, DYSMENORRHOEA, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN AND THE PELVIC PAIN AND ABDOMINAL PAIN LOWER WAS RESOLVING. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR COMPLICATION OF DEVICE INSERTION WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ANXIETY, AUTOIMMUNE DISORDER, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, FALLOPIAN TUBE PERFORATION, HYPERSENSITIVITY, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE DID NOT WORSENED A PREVIOUSLY EXISTING INJURY/CONDITION. SHE WAS ADVISED OF (UNSPECIFIED) COMPLICATIONS OR PROBLEMS THAT OCCURRED AT THE TIME OF ESSURE PLACEMENT PROCEDURE. SHE DID NOT RETAIN THE ESSURE DEVICE OR ANY PORTION OF IT. SHE DID NOT HAD ANY COMPLICATIONS FROM ESSURE REMOVAL PROCEDURE. ESSURE DID NOT CAUSED BIRTH DEFECTS. THE PROXIMAL TIP OF THE ESSURE COIL WAS ACTUALLY POKING SUPERIORLY TO THE TUBE, ONCE THE TUBE HAD BEEN REMOVED, THE COIL WAS ENCASED ENTIRELY WITHIN THIS, LEFT CORNUAL REGION OF THE UTERUS WAS HEMOSTATIC AND WAS ABLE TO BE CAUTERIZED AS TAKING THE BITE IN THIS AREA ACTUALLY REMOVED THE COIL IN ITS ENTIRETY. IT WAS REPORTED THAT SHE HAD ESSURE DONE BUT SHE KNOCKED OUT AND RECOVERY WAS EASY PEASY LEMON SQUEEZY. DIAGNOSTIC RESULTS: HYSTEROSALPINGOGRAM (HSG) ON (B)(6) 2013, ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED, TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WERE DESCRIBED/CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN. LOT NUMBER: 901333, MANUFACTURE DATE: (B)(6) 2011, EXPIRATION DATE: (B)(6) 2014. LOT NUMBER: 927086, MANUFACTURE DATE: (B)(6) 2011, EXPIRATION DATE: (B)(6) 2014. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET RECEIVED. EVENT ADDED: DEPRESSION AND MENTAL ANGUISH. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('PERFORATION/ PERFORATION (FALLOPIAN TUBE DIAGNOSIS: (S))'), DEVICE EXPULSION ('MIGRATION OF ESSURE DEVICE/ MIGRATION OF ESSURE DEVICE- LOCATION OF DEVICE: UNKNOWN/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS') AND AUTOIMMUNE DISORDER ('AUTO-IMMUNE REACTION/ AUTOIMMUNE DISORDER') IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 927086, 901333) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA IUD. CONCURRENT CONDITIONS INCLUDED ARTHRITIS SINCE 2015, CIRRHOSIS LIVER SINCE 2015, HYPERTENSION SINCE 2008, IRRITABLE BOWEL SYNDROME SINCE 2007, HYPOTHYROIDISM SINCE 2003, DIABETES SINCE 2001, PSORIATIC ARTHRITIS SINCE 2000, C-SECTION AND MORBID OBESITY. CONCOMITANT PRODUCTS INCLUDED LEVONORGESTREL (MIRENA) (B)(6) 2011 TO (B)(6) 2013 FOR CONTRACEPTION AS WELL AS PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("SEVERE PELVIC PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS - CONDITION: DEPRESSION") AND ANXIETY ("MENTAL ANGUISH / PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS - CONDITION: ANXIETY"). IN (B)(6) 2012, THE PATIENT EXPERIENCED AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION"). ON (B)(6) 2016, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("LEFT LOWER QUADRANT PAIN"), 4 YEARS 3 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), COMPLICATION OF DEVICE INSERTION ("COMPLICATION OF DEVICE INSERTION"), BACK PAIN ("LOWER BACK PAIN") AND ABDOMINAL PAIN ("ABDOMINAL AREA PAIN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). THE PATIENT WAS TREATED WITH ADALIMUMAB (HUMIRA), GLIBENCLAMIDE (GLYBURIDE), LEVOTHYROXINE SODIUM (SYNTHROID), LOSARTAN POTASSIUM (COZAAR), NIFEDIPINE, OMEPRAZOLE (PRILOSEC), RANITIDINE HYDROCHLORIDE (ZANTAC), VENLAFAXINE HYDROCHLORIDE (EFFEXOR) AND SURGERY (HYSTERECTOMY (PARTIAL), DIAGNOSTIC LAPAROSCOPY, BILATERAL SALPINGECTOMY WITH REMOVAL OF ESSURE COILS). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE EXPULSION, AUTOIMMUNE DISORDER, MENSTRUAL DISORDER, HYPERSENSITIVITY, COMPLICATION OF DEVICE INSERTION, DYSMENORRHOEA, DEPRESSION, ANXIETY AND WEIGHT INCREASED OUTCOME WAS UNKNOWN, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, BACK PAIN AND ABDOMINAL PAIN HAD RESOLVED AND THE ABDOMINAL PAIN LOWER WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANXIETY, AUTOIMMUNE DISORDER, BACK PAIN, COMPLICATION OF DEVICE INSERTION, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, FALLOPIAN TUBE PERFORATION, HYPERSENSITIVITY, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE DID NOT WORSENED A PREVIOUSLY EXISTING INJURY/CONDITION. SHE WAS ADVISED OF (UNSPECIFIED) COMPLICATIONS OR PROBLEMS THAT OCCURRED AT THE TIME OF ESSURE PLACEMENT PROCEDURE. SHE DID NOT RETAIN THE ESSURE DEVICE OR ANY PORTION OF IT. SHE DID NOT HAD ANY COMPLICATIONS FROM ESSURE REMOVAL PROCEDURE. ESSURE DID NOT CAUSED BIRTH DEFECTS. THE PROXIMAL TIP OF THE ESSURE COIL WAS ACTUALLY POKING SUPERIORLY TO THE TUBE, ONCE THE TUBE HAD BEEN REMOVED, THE COIL WAS ENCASED ENTIRELY WITHIN THIS, LEFT CORNUAL REGION OF THE UTERUS WAS HEMOSTATIC AND WAS ABLE TO BE CAUTERIZED AS TAKING THE BITE IN THIS AREA ACTUALLY REMOVED THE COIL IN ITS ENTIRETY. IT WAS REPORTED THAT SHE HAD ESSURE DONE BUT SHE KNOCKED OUT AND RECOVERY WAS EASY PEASY LEMON SQUEEZY. CURRENT WEIGHT 250 LBS. PLAINTIFF RECEIVED TREATMENT FOR PAIN, BLEEDING, MIGRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 40 KG/SQM. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WERE DESCRIBED/CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN. LOT NUMBER: 901333 MANUFACTURE DATE: 2011/09, EXPIRATION DATE: 2014/09. LOT NUMBER: 927086 MANUFACTURE DATE: 2011/12, EXPIRATION DATE: 2014/12. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PFS RECEIVED. REPORTER INFORMATION ADDED. EVENT OUTCOME UPDATED FOR PELVIC PAIN, BACK PAIN, ABDOMINAL PAIN, VAGINAL HEMORRHAGE AND MENORRHAGIA. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('PERFORATION/ PERFORATION (FALLOPIAN TUBE DIAGNOSIS: (S))') AND DEVICE EXPULSION ('MIGRATION OF ESSURE DEVICE/ MIGRATION OF ESSURE DEVICE- LOCATION OF DEVICE: UNKNOWN/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS') IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 927086, 901333) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA IUD. CONCURRENT CONDITIONS INCLUDED ARTHRITIS SINCE 2015, CIRRHOSIS LIVER SINCE 2015, HYPERTENSION SINCE 2008, IRRITABLE BOWEL SYNDROME SINCE 2007, HYPOTHYROIDISM SINCE 2003, DIABETES SINCE 2001, PSORIATIC ARTHRITIS SINCE 2000, C-SECTION AND MORBID OBESITY. CONCOMITANT PRODUCTS INCLUDED LEVONORGESTREL (MIRENA) (B)(6) 2011 TO FEBRUARY 2013 FOR CONTRACEPTION AS WELL AS PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN MARCH 2012, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("SEVERE PELVIC PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS - CONDITION: DEPRESSION") AND ANXIETY ("MENTAL ANGUISH / PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS - CONDITION: ANXIETY"). IN APRIL 2012, THE PATIENT EXPERIENCED AUTOIMMUNE DISORDER ("AUTO-IMMUNE REACTION/ AUTOIMMUNE DISORDER") AND HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION"). ON (B)(6) 2016, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("LEFT LOWER QUADRANT PAIN"), 4 YEARS 3 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), COMPLICATION OF DEVICE INSERTION ("COMPLICATION OF DEVICE INSERTION"), BACK PAIN ("LOWER BACK PAIN") AND ABDOMINAL PAIN ("ABDOMINAL AREA PAIN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). THE PATIENT WAS TREATED WITH ADALIMUMAB (HUMIRA), GLIBENCLAMIDE (GLYBURIDE), LEVOTHYROXINE SODIUM (SYNTHROID), LOSARTAN POTASSIUM (COZAAR), NIFEDIPINE, OMEPRAZOLE (PRILOSEC), RANITIDINE HYDROCHLORIDE (ZANTAC), VENLAFAXINE HYDROCHLORIDE (EFFEXOR) AND SURGERY (HYSTERECTOMY (PARTIAL), DIAGNOSTIC LAPAROSCOPY, BILATERAL SALPINGECTOMY WITH REMOVAL OF ESSURE COILS). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE EXPULSION, AUTOIMMUNE DISORDER, MENSTRUAL DISORDER, HYPERSENSITIVITY, COMPLICATION OF DEVICE INSERTION, DYSMENORRHOEA, DEPRESSION, ANXIETY AND WEIGHT INCREASED OUTCOME WAS UNKNOWN, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, BACK PAIN AND ABDOMINAL PAIN HAD RESOLVED AND THE ABDOMINAL PAIN LOWER WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANXIETY, AUTOIMMUNE DISORDER, BACK PAIN, COMPLICATION OF DEVICE INSERTION, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, FALLOPIAN TUBE PERFORATION, HYPERSENSITIVITY, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE DID NOT WORSENED A PREVIOUSLY EXISTING INJURY/CONDITION. SHE WAS ADVISED OF (UNSPECIFIED) COMPLICATIONS OR PROBLEMS THAT OCCURRED AT THE TIME OF ESSURE PLACEMENT PROCEDURE. SHE DID NOT RETAIN THE ESSURE DEVICE OR ANY PORTION OF IT. SHE DID NOT HAD ANY COMPLICATIONS FROM ESSURE REMOVAL PROCEDURE. ESSURE DID NOT CAUSED BIRTH DEFECTS. THE PROXIMAL TIP OF THE ESSURE COIL WAS ACTUALLY POKING SUPERIORLY TO THE TUBE, ONCE THE TUBE HAD BEEN REMOVED, THE COIL WAS ENCASED ENTIRELY WITHIN THIS, LEFT CORNUAL REGION OF THE UTERUS WAS HEMOSTATIC AND WAS ABLE TO BE CAUTERIZED AS TAKING THE BITE IN THIS AREA ACTUALLY REMOVED THE COIL IN ITS ENTIRETY. IT WAS REPORTED THAT SHE HAD ESSURE DONE BUT SHE KNOCKED OUT AND RECOVERY WAS EASY PEASY LEMON SQUEEZY. CURRENT WEIGHT 250 LBS. PLAINTIFF RECEIVED TREATMENT FOR PAIN, BLEEDING, MIGRATION DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 40 KG/SQM. LOT NUMBER: 901333 MANUFACTURING DATE: 2011-09 EXPIRATION DATE: 2014-09 . LOT NUMBER: 927086 MANUFACTURING DATE: 2011-12 EXPIRATION DATE: 2014-12 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: QUALITY-SAFETY EVALUATION OF PTC WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('PERFORATION/ PERFORATION (FALLOPIAN TUBE DIAGNOSIS: (S))'), DEVICE EXPULSION ('MIGRATION OF ESSURE DEVICE/ MIGRATION OF ESSURE DEVICE- LOCATION OF DEVICE: UNKNOWN/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS/PROBABLE EXPULSION OF RIGHT ESSURE DEVICE') AND DEVICE DISLOCATION ('THERE IS SINGLE ESSURE DEVICE PROJECTING IN THE LEFT HEMI PELVIS') IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 927086, 901333) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED LOW BACK PAIN, BACKACHE, AND DEGENERATIVE JOINT DISEASE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA IUD. CONCURRENT CONDITIONS INCLUDED ARTHRITIS SINCE 2015, CIRRHOSIS LIVER SINCE 2015, HYPERTENSION SINCE 2008, IRRITABLE BOWEL SYNDROME SINCE 2007, HYPOTHYROIDISM SINCE 2003, DIABETES SINCE 2001, PSORIATIC ARTHRITIS SINCE 2000, C-SECTION AND MORBID OBESITY. CONCOMITANT PRODUCTS INCLUDED LEVONORGESTREL (MIRENA) (B)(6)2011 TO (B)(6) 2013 FOR CONTRACEPTION AS WELL AS PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("SEVERE PELVIC PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), HEAVY MENSTRUAL BLEEDING ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS - CONDITION: DEPRESSION") AND ANXIETY ("MENTAL ANGUISH / PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS - CONDITION: ANXIETY"). IN (B)(6) 2012, THE PATIENT EXPERIENCED AUTOIMMUNE DISORDER ("AUTO-IMMUNE REACTION/ AUTOIMMUNE DISORDER") AND HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION"). ON (B)(6) 2016, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("LEFT LOWER QUADRANT PAIN"), 4 YEARS 3 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), COMPLICATION OF DEVICE INSERTION ("COMPLICATION OF DEVICE INSERTION"), BACK PAIN ("LOWER BACK PAIN") AND ABDOMINAL PAIN ("ABDOMINAL AREA PAIN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). THE PATIENT WAS TREATED WITH ADALIMUMAB (HUMIRA), GLIBENCLAMIDE (GLYBURIDE), LEVOTHYROXINE SODIUM (SYNTHROID), LOSARTAN POTASSIUM (COZAAR), NIFEDIPINE, OMEPRAZOLE (PRILOSEC), RANITIDINE HYDROCHLORIDE (ZANTAC), VENLAFAXINE HYDROCHLORIDE (EFFEXOR) AND SURGERY (DIAGNOSTIC LAPAROSCOPY BILATERAL SALPINGECTOMY WITH REMOVAL OF ESSURE COILS IN TOTAL AND HYSTERECTOMY (PARTIAL), DIAGNOSTIC LAPAROSCOPY, BILATERAL SALPINGECTOMY WITH REMOVAL OF ESSURE COILS). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE EXPULSION, DEVICE DISLOCATION, AUTOIMMUNE DISORDER, MENSTRUAL DISORDER, HYPERSENSITIVITY, COMPLICATION OF DEVICE INSERTION, DYSMENORRHOEA, DEPRESSION, ANXIETY AND WEIGHT INCREASED OUTCOME WAS UNKNOWN, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, BACK PAIN AND ABDOMINAL PAIN HAD RESOLVED AND THE ABDOMINAL PAIN LOWER WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANXIETY, AUTOIMMUNE DISORDER, BACK PAIN, COMPLICATION OF DEVICE INSERTION, DEPRESSION, DEVICE DISLOCATION, DEVICE EXPULSION, DYSMENORRHOEA, FALLOPIAN TUBE PERFORATION, HEAVY MENSTRUAL BLEEDING, HYPERSENSITIVITY, MENSTRUAL DISORDER, PELVIC PAIN, VAGINAL HAEMORRHAGE, AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE DID NOT WORSENED A PREVIOUSLY EXISTING INJURY/CONDITION. SHE WAS ADVISED OF (UNSPECIFIED) COMPLICATIONS OR PROBLEMS THAT OCCURRED AT THE TIME OF ESSURE PLACEMENT PROCEDURE. SHE DID NOT RETAIN THE ESSURE DEVICE OR ANY PORTION OF IT. SHE DID NOT HAD ANY COMPLICATIONS FROM ESSURE REMOVAL PROCEDURE. ESSURE DID NOT CAUSED BIRTH DEFECTS. THE PROXIMAL TIP OF THE ESSURE COIL WAS ACTUALLY POKING SUPERIORLY TO THE TUBE, ONCE THE TUBE HAD BEEN REMOVED, THE COIL WAS ENCASED ENTIRELY WITHIN THIS, LEFT CORNUAL REGION OF THE UTERUS WAS HEMOSTATIC AND WAS ABLE TO BE CAUTERIZED AS TAKING THE BITE IN THIS AREA ACTUALLY REMOVED THE COIL IN ITS ENTIRETY. IT WAS REPORTED THAT SHE HAD ESSURE DONE BUT SHE KNOCKED OUT AND RECOVERY WAS EASY PEASY LEMON SQUEEZY. CURRENT WEIGHT 250 LBS. PLAINTIFF RECEIVED TREATMENT FOR PAIN, BLEEDING, MIGRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 40 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: RESULTS: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED, TOTAL BILATERAL OCCLUSION. LOT NUMBER: 901333 MANUFACTURING DATE: 2011-09 EXPIRATION DATE: 2014-09. LOT NUMBER: 927086 MANUFACTURING DATE: 2011-12 EXPIRATION DATE: 2014-12. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WAS/WERE REPORTED FROM PATIENT¿S MEDICAL RECORD: DEVICE DISLOCATION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2021: MEDICAL RECORD RECEIVED: EVENT 'THERE IS SINGLE ESSURE DEVICE PROJECTING IN THE LEFT HEMI PELVIS', MEDICAL HISTORY WERE ADDED. PATIENT DEMOGRAPHIC WAS UPDATED. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('PERFORATION/ PERFORATION (FALLOPIAN TUBE DIAGNOSIS: (S))'), DEVICE EXPULSION ('MIGRATION OF ESSURE DEVICE/ MIGRATION OF ESSURE DEVICE- LOCATION OF DEVICE: UNKNOWN/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS/PROBABLE EXPULSION OF RIGHT ESSURE DEVICE') AND DEVICE DISLOCATION ('THERE IS SINGLE ESSURE DEVICE PROJECTING IN THE LEFT HEMI PELVIS') IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 927086, 901333) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED LOW BACK PAIN, BACKACHE AND DEGENERATIVE JOINT DISEASE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA IUD. CONCURRENT CONDITIONS INCLUDED ARTHRITIS SINCE 2015, CIRRHOSIS LIVER SINCE 2015, HYPERTENSION SINCE 2008, IRRITABLE BOWEL SYNDROME SINCE 2007, HYPOTHYROIDISM SINCE 2003, DIABETES SINCE 2001, PSORIATIC ARTHRITIS SINCE 2000, C-SECTION AND MORBID OBESITY. CONCOMITANT PRODUCTS INCLUDED LEVONORGESTREL (MIRENA) (B)(6) 2011 TO (B)(6) 2013 FOR CONTRACEPTION AS WELL AS PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("SEVERE PELVIC PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), HEAVY MENSTRUAL BLEEDING ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS - CONDITION: DEPRESSION") AND ANXIETY ("MENTAL ANGUISH / PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS - CONDITION: ANXIETY"). IN (B)(6) 2012, THE PATIENT EXPERIENCED AUTOIMMUNE DISORDER ("AUTO-IMMUNE REACTION/ AUTOIMMUNE DISORDER") AND HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION"). ON (B)(6) 2016, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("LEFT LOWER QUADRANT PAIN"), 4 YEARS 3 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), COMPLICATION OF DEVICE INSERTION ("COMPLICATION OF DEVICE INSERTION"), BACK PAIN ("LOWER BACK PAIN") AND ABDOMINAL PAIN ("ABDOMINAL AREA PAIN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). THE PATIENT WAS TREATED WITH ADALIMUMAB (HUMIRA), GLIBENCLAMIDE (GLYBURIDE), LEVOTHYROXINE SODIUM (SYNTHROID), LOSARTAN POTASSIUM (COZAAR), NIFEDIPINE, OMEPRAZOLE (PRILOSEC), RANITIDINE HYDROCHLORIDE (ZANTAC), VENLAFAXINE HYDROCHLORIDE (EFFEXOR) AND SURGERY (DIAGNOSTIC LAPAROSCOPY BILATERAL SALPINGECTOMY WITH REMOVAL OF ESSURE COILS IN TOTAL AND HYSTERECTOMY (PARTIAL), DIAGNOSTIC LAPAROSCOPY, BILATERAL SALPINGECTOMY WITH REMOVAL OF ESSURE COILS). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE EXPULSION, DEVICE DISLOCATION, AUTOIMMUNE DISORDER, MENSTRUAL DISORDER, HYPERSENSITIVITY, COMPLICATION OF DEVICE INSERTION, DYSMENORRHOEA, DEPRESSION, ANXIETY AND WEIGHT INCREASED OUTCOME WAS UNKNOWN, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, BACK PAIN AND ABDOMINAL PAIN HAD RESOLVED AND THE ABDOMINAL PAIN LOWER WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANXIETY, AUTOIMMUNE DISORDER, BACK PAIN, COMPLICATION OF DEVICE INSERTION, DEPRESSION, DEVICE DISLOCATION, DEVICE EXPULSION, DYSMENORRHOEA, FALLOPIAN TUBE PERFORATION, HEAVY MENSTRUAL BLEEDING, HYPERSENSITIVITY, MENSTRUAL DISORDER, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE DID NOT WORSENED A PREVIOUSLY EXISTING INJURY/CONDITION. SHE WAS ADVISED OF (UNSPECIFIED) COMPLICATIONS OR PROBLEMS THAT OCCURRED AT THE TIME OF ESSURE PLACEMENT PROCEDURE. SHE DID NOT RETAIN THE ESSURE DEVICE OR ANY PORTION OF IT. SHE DID NOT HAD ANY COMPLICATIONS FROM ESSURE REMOVAL PROCEDURE. ESSURE DID NOT CAUSED BIRTH DEFECTS. THE PROXIMAL TIP OF THE ESSURE COIL WAS ACTUALLY POKING SUPERIORLY TO THE TUBE, ONCE THE TUBE HAD BEEN REMOVED, THE COIL WAS ENCASED ENTIRELY WITHIN THIS, LEFT CORNUAL REGION OF THE UTERUS WAS HEMOSTATIC AND WAS ABLE TO BE CAUTERIZED AS TAKING THE BITE IN THIS AREA ACTUALLY REMOVED THE COIL IN ITS ENTIRETY. IT WAS REPORTED THAT SHE HAD ESSURE DONE BUT SHE KNOCKED OUT AND RECOVERY WAS EASY PEASY LEMON SQUEEZY. CURRENT WEIGHT 250 LBS. PLAINTIFF RECEIVED TREATMENT FOR PAIN, BLEEDING, MIGRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 40 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: RESULTS: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED, TOTAL BILATERAL OCCLUSION. LOT NUMBER: 901333 MANUFACTURING DATE: 2011-09 EXPIRATION DATE: 2014-09. LOT NUMBER: 927086 MANUFACTURING DATE: 2011-12 EXPIRATION DATE: 2014-12. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WAS/WERE REPORTED FROM PATIENT¿S MEDICAL RECORD: DEVICE DISLOCATION. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-MAY-2021: QUALITY SAFETY EVALUATION OF PTC WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PERFORATION/ PERFORATION (FALLOPIAN TUBE DIAGNOSIS: (S))") AND AUTOIMMUNE DISORDER ("AUTO-IMMUNE REACTION/ AUTOIMMUNE DISORDER") IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 927086, 901333) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6)2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6)2016, 4 YEARS 3 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("LEFT LOWER QUADRANT PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("SEVERE PELVIC PAIN"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION") AND COMPLICATION OF DEVICE INSERTION ("COMPLICATION OF DEVICE INSERTION"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL), DIAGNOSTIC LAPAROSCOPY, BILATERAL SALPINGECTOMY WITH REMOVAL OF ESSURE COILS). ESSURE WAS REMOVED ON (B)(6)2016. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, AUTOIMMUNE DISORDER, MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, MENORRHAGIA, HYPERSENSITIVITY AND COMPLICATION OF DEVICE INSERTION OUTCOME WAS UNKNOWN AND THE PELVIC PAIN AND ABDOMINAL PAIN LOWER WAS RESOLVING. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR COMPLICATION OF DEVICE INSERTION WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, AUTOIMMUNE DISORDER, FALLOPIAN TUBE PERFORATION, HYPERSENSITIVITY, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE DID NOT WORSENED A PREVIOUSLY EXISTING INJURY/CONDITION. SHE WAS ADVISED OF (UNSPECIFIED) COMPLICATIONS OR PROBLEMS THAT OCCURRED AT THE TIME OF ESSURE PLACEMENT PROCEDURE. SHE DID NOT RETAIN THE ESSURE DEVICE OR ANY PORTION OF IT. SHE DID NOT HAD ANY COMPLICATIONS FROM ESSURE REMOVAL PROCEDURE. ESSURE DID NOT CAUSED BIRTH DEFECTS. DIAGNOSTIC RESULTS: HYSTEROSALPINGOGRAM (HSG) ON (B)(6)2013, ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED, TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2018: PLAINTIFF FACT SHEET RECEIVED. REPORTER INFORMATION, PATIENT¿S DEMOGRAPHIC INFORMATION, RELEVANT HISTORY AND LAB DATA UPDATED. ESSURE LOT NUMBER AND REMOVAL DATE (B)(6)2016 WAS ADDED. EVENTS AUTOIMMUNE DISORDER, PERFORATION (FALLOPIAN TUBE DIAGNOSIS: (S)) WERE CLUBBED WITH PREVIOUSLY REPORTED EVENTS, ALSO EVENT PERFORATION WAS RECODED FROM UTERINE PERFORATION TO FALLOPIAN TUBE PERFORATION. EVENTS VAGINAL HAEMORRHAGE, MENORRHAGIA, HYPERSENSITIVITY, ABDOMINAL PAIN LOWER, COMPLICATION OF DEVICE INSERTION WERE NEWLY ADDED. INCIDENT AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("PERFORATION") AND AUTOIMMUNE DISORDER ("AUTO-IMMUNE REACTION") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("SEVERE PELVIC PAIN") AND MENSTRUAL DISORDER ("MENSTRUATION ISSUES"). THE PATIENT WAS TREATED WITH SURGERY (PATIENT UNDERWENT REMOVAL OF ESSURE DEVICE). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, AUTOIMMUNE DISORDER, PELVIC PAIN AND MENSTRUAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED AUTOIMMUNE DISORDER, MENSTRUAL DISORDER, PELVIC PAIN AND UTERINE PERFORATION TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. INCIDENT. NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 724875 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 927086, 901333 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Other| R | ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| MIRENA| MIRENA| MIRENA| MIRENA| MIRENA |