ESSURE
Report
- Report Number
- 2951250-2019-03143
- Event Type
- Injury
- Date Received
- June 28, 2019
- Date of Event
- April 1, 2005
- Report Date
- July 17, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PHYSICAL PAIN/ PAIN/ PELVIC AREA') AND MENORRHAGIA ('ABNORMAL BLEEDING (MENORRHAGIA)') IN A 39-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12269948-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "ABLATION / ON (B)(6) 2005 ESSURE TUBAL STERILIZATION, HYSTEROSCOPY, HYDROTHERMAL ABLATION OF THE ENDOMETRIUM" AND DEVICE INEFFECTIVE "FAILURE TO OCCLUDE FALLOPIAN TUBE(RIGHT SIDE)/HER ESSURE STERILIZATION FAILED ON THE RIGHT SIDE". THE PATIENT'S MEDICAL HISTORY INCLUDED ENDOMETRIAL BIOPSY IN (B)(6) 2005, ABDOMINAL PAIN LOWER, ECZEMA, CERVICAL DYSPLASIA, D & C AND LOOP ELECTROSURGICAL EXCISION PROCEDURE. CONCURRENT CONDITIONS INCLUDED HYPERTENSION, MENOMETRORRHAGIA, FACIAL PUFFINESS, PERIORBITAL SWELLING, ITCHING EYES, EYE CRUSTING, HOT FLASHES, BACK PAIN, SPOTTING BETWEEN MENSES, UTERINE BLEEDING, ADENOMYOSIS, UTERINE LEIOMYOMA, FIBROIDS, MENSES IRREGULAR, SKIN SWELLING AND ALLERGIC EXANTHEMA. CONCOMITANT PRODUCTS INCLUDED HYDROCHLOROTHIAZIDE;LISINOPRIL (LISINOPRIL HYDROCHLORTHIAZIDE SANDOZ) SINCE(B)(6) 2004 FOR HYPERTENSION AS WELL AS BETAMETHASONE (CELESTONE), BUPROPION HYDROCHLORIDE (WELLBUTRIN), HYDROCHLOROTHIAZIDE (HYPOTHIAZIDE) AND MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) SINCE (B)(6) 2005. ON (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON (B)(6) 2005, THE PATIENT EXPERIENCED RASH ("RASHES OR SKIN CONDITIONS TYPE: DERMATOSIS/ RASH ON FACE") AND DERMATITIS ("RASHES OR SKIN CONDITIONS - TYPE: DERMATITIS"), 30 DAYS AFTER INSERTION OF ESSURE (ESS205). ON (B)(6) 2005, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON (B)(6) 2010, THE PATIENT EXPERIENCED DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE, LOCATION UNKNOWN / ESSURE SPRINGS HAVING COME OUT OF HER VAGINA/THEREIS NO ESSURE SPRING IN THE LEFT SIDE."). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: MENTAL ANGUISH"). THE PATIENT WAS TREATED WITH CELECOXIB (CELEXA), DIPHENHYDRAMINE HYDROCHLORIDE, NSAIDS, PARACETAMOL (ACETAMINOPHEN) AND SURGERY (ABLATION ON (B)(6) 2005 / NOVASURE ABLATION AND HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2010. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING AND THE MENORRHAGIA, DEVICE EXPULSION, VAGINAL HAEMORRHAGE, DEPRESSION, ANXIETY, RASH AND DERMATITIS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DERMATITIS, DEVICE EXPULSION, MENORRHAGIA, PELVIC PAIN, RASH AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: THE ESSURE DEVICE WAS INSERTED ON THE PATIENT'S LEFT AND CONFIRMATION OF PLACEMENT WAS VISUALIZED WITH 0 NUMBER OF COILS VISUALIZED AFTER PLACEMENT. ON PATIENT'S RIGHT THE ESSURE DEVICE WAS INSERTED. THERE WAS A SMALL AMOUNT OF RESISTANCE ON THIS SIDE AND THERE WERE 16 COILS VISUALIZED AFTER PLACEMENT. WHEN SHE WENT TO THE RESTROOM SHE NOTICED A SPRING COIL AND SAVED IT AND HAS BROUGHT IT IN TODAY. IDENTIFICATION OF THE SAMPLE CONFIRMS IT TO BE AN ESSURE SPRING. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2005: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. UNILATERAL OCCLUSION (LEFT TUBE OCCLUDED).. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: MENORRHAGIA, RASH, DERMATITIS. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA MEDICAL RECORD: DEVICE EXPULSION. LOT NUMBER REPORT (12269948) IS INVALID MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: UPDATE OF INFORMATION (BATCH NUMBER IS NOT VALID). NO VALID LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCE'S 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 PELVIC PAIN ('PHYSICAL PAIN/ PAIN/ PELVIC AREA') AND MENORRHAGIA ('ABNORMAL BLEEDING (MENORRHAGIA)') IN A 39-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12269948-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "ABLATION / ON (B)(6) 2005 ESSURE TUBAL STERILIZATION, HYSTEROSCOPY, HYDROTHERMAL ABLATION OF THE ENDOMETRIUM" AND DEVICE INEFFECTIVE "FAILURE TO OCCLUDE FALLOPIAN TUBE(RIGHT SIDE)/HER ESSURE STERILIZATION FAILED ON THE RIGHT SIDE". THE PATIENT'S MEDICAL HISTORY INCLUDED ENDOMETRIAL BIOPSY IN (B)(6) 2005, CRAMP IN LOWER ABDOMEN, ECZEMA, CERVICAL DYSPLASIA, D & C AND LOOP ELECTROSURGICAL EXCISION PROCEDURE. CONCURRENT CONDITIONS INCLUDED HYPERTENSION, MENOMETRORRHAGIA, FACIAL PUFFINESS, PERIORBITAL SWELLING, ITCHING EYES, EYE CRUSTING, HOT FLASHES, BACK PAIN, SPOTTING BETWEEN MENSES, UTERINE BLEEDING, ADENOMYOSIS, UTERINE LEIOMYOMA, FIBROIDS, MENSES IRREGULAR, SKIN SWELLING AND ALLERGIC EXANTHEMA. CONCOMITANT PRODUCTS INCLUDED HYDROCHLOROTHIAZIDE;LISINOPRIL (LISINOPRIL HYDROCHLORTHIAZIDE SANDOZ) SINCE (B)(6) 2004 FOR HYPERTENSION AS WELL AS BETAMETHASONE (CELESTONE), BUPROPION HYDROCHLORIDE (WELLBUTRIN), HYDROCHLOROTHIAZIDE (HYDROTHIAZIDE) AND MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) SINCE (B)(6) 2005. ON (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6) 2005, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 5 MONTHS 8 DAYS AFTER INSERTION OF ESSURE (ESS205). IN (B)(6) 2005, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: MENTAL ANGUISH"). ON (B)(6) 2005, THE PATIENT EXPERIENCED RASH ("RASHES OR SKIN CONDITIONS TYPE: DERMATISIS/ RASH ON FACE") AND DERMATITIS ("RASHES OR SKIN CONDITIONS - TYPE: DERMATITIS"). ON (B)(6) 2005, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON (B)(6) 2010, THE PATIENT EXPERIENCED DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE, LOCATION UNKNOWN / ESSURE SPRINGS HAVING COME OUT OF HER VAGINA/THEREIS NO ESSURE SPRING IN THE LEFT SIDE."). THE PATIENT WAS TREATED WITH CELECOXIB (CELEXA), DIPHENHYDRAMINE HYDROCHLORIDE, NSAIDS, PARACETAMOL (ACETAMINOPHEN) AND SURGERY (ABLATION ON (B)(6) 2005 / NOVASURE ABLATION AND HYSTERECTOMY WITH SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2010. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA AND VAGINAL HAEMORRHAGE HAD RESOLVED AND THE DEVICE EXPULSION, DEPRESSION, ANXIETY, RASH AND DERMATITIS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DERMATITIS, DEVICE EXPULSION, MENORRHAGIA, PELVIC PAIN, RASH AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: THE ESSURE DEVICE WAS INSERTED ON THE PATIENT'S LEFT AND CONFIRMATION OF PLACEMENT WAS VISUALIZED WITH 0 NUMBER OF COILS VISUALIZED AFTER PLACEMENT. ON PATIENT'S RIGHT THE ESSURE DEVICE WAS INSERTED. THERE WAS A SMALL AMOUNT OF RESISTANCE ON THIS SIDE AND THERE WERE 16 COILS VISUALIZED AFTER PLACEMENT. WHEN SHE WENT TO THE RESTROOM SHE NOTICED A SPRING COIL AND SAVED IT AND HAS BROUGHT IT IN TODAY. IDENTIFICATION OF THE SAMPLE CONFIRMS IT TO BE AN ESSURE SPRING. TREATMENT RECEIVED FOR PAIN , BLEEDING, MIGRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2005: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. UNILATERAL OCCLUSION (LEFT TUBE OCCLUDED). UNSUCCESSFUL OCCLUSION OF RIGHT FALLOPIAN TUBE. PLEASE ALSO PROVIDE THE DATE ON WHICH YOU RECEIVED YOUR RESULTS. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: MENORRHAGIA, RASH, DERMATITIS. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA MEDICAL RECORD: DEVICE EXPULSION. LOT NUMBER REPORT (12269948) IS INVALID. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PFS RECEIVED. OUTCOME OF EVENT : PHYSICAL PAIN/ PAIN/ PELVIC AREA WAS ADDED. RCC COMMENT WAS ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PHYSICAL PAIN/ PAIN/ PELVIC AREA') AND MENORRHAGIA ('ABNORMAL BLEEDING (MENORRHAGIA)') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12269948-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "ABLATION / ON (B)(6) 2005 ESSURE TUBAL STERILIZATION, HYSTEROSCOPY, HYDROTHERMAL ABLATION OF THE ENDOMETRIUM" AND DEVICE INEFFECTIVE "FAILURE TO OCCLUDE FALLOPIAN TUBE(RIGHT SIDE)/HER ESSURE STERILIZATION FAILED ON THE RIGHT SIDE". THE PATIENT'S MEDICAL HISTORY INCLUDED ENDOMETRIAL BIOPSY IN (B)(6) 2005, CRAMP IN LOWER ABDOMEN, ECZEMA, CERVICAL DYSPLASIA, D & C AND LOOP ELECTROSURGICAL EXCISION PROCEDURE. CONCURRENT CONDITIONS INCLUDED HYPERTENSION, MENOMETRORRHAGIA, FACIAL PUFFINESS, PERIORBITAL SWELLING, ITCHING EYES, EYE CRUSTING, HOT FLASHES, BACK PAIN, SPOTTING BETWEEN MENSES, UTERINE BLEEDING, ADENOMYOSIS, UTERINE LEIOMYOMA, FIBROIDS, MENSES IRREGULAR, SKIN SWELLING AND ALLERGIC EXANTHEMA. CONCOMITANT PRODUCTS INCLUDED HYDROCHLOROTHIAZIDE;LISINOPRIL (LISINOPRIL HYDROCHLORTHIAZIDE SANDOZ) SINCE (B)(6) 2004 FOR HYPERTENSION AS WELL AS BETAMETHASONE (CELESTONE), BUPROPION HYDROCHLORIDE (WELLBUTRIN), HYDROCHLOROTHIAZIDE (HYDROTHIAZIDE) AND MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) SINCE (B)(6) 2005. ON (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6) 2005, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 5 MONTHS 8 DAYS AFTER INSERTION OF ESSURE (ESS205). IN (B)(6) 2005, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: MENTAL ANGUISH"). ON B)(6) 2005, THE PATIENT EXPERIENCED RASH ("RASHES OR SKIN CONDITIONS TYPE: DERMATISIS/ RASH ON FACE") AND DERMATITIS ("RASHES OR SKIN CONDITIONS - TYPE: DERMATITIS"). ON (B)(6) 2005, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON (B)(6) 2010, THE PATIENT EXPERIENCED DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE, LOCATION UNKNOWN / ESSURE SPRINGS HAVING COME OUT OF HER VAGINA/THEREIS NO ESSURE SPRING IN THE LEFT SIDE."). THE PATIENT WAS TREATED WITH CELECOXIB (CELEXA), DIPHENHYDRAMINE HYDROCHLORIDE, NSAIDS, PARACETAMOL (ACETAMINOPHEN) AND SURGERY (ABLATION ON 25-MAR-2005 / NOVASURE ABLATION AND HYSTERECTOMY WITH SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2010. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA AND VAGINAL HAEMORRHAGE HAD RESOLVED AND THE DEVICE EXPULSION, DEPRESSION, ANXIETY, RASH AND DERMATITIS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DERMATITIS, DEVICE EXPULSION, MENORRHAGIA, PELVIC PAIN, RASH AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: THE ESSURE DEVICE WAS INSERTED ON THE PATIENT'S LEFT AND CONFIRMATION OF PLACEMENT WAS VISUALIZED WITH 0 NUMBER OF COILS VISUALIZED AFTER PLACEMENT. ON PATIENT'S RIGHT THE ESSURE DEVICE WAS INSERTED. THERE WAS A SMALL AMOUNT OF RESISTANCE ON THIS SIDE AND THERE WERE 16 COILS VISUALIZED AFTER PLACEMENT. WHEN SHE WENT TO THE RESTROOM SHE NOTICED A SPRING COIL AND SAVED IT AND HAS BROUGHT IT IN TODAY. IDENTIFICATION OF THE SAMPLE CONFIRMS IT TO BE AN ESSURE SPRING. TREATMENT RECEIVED FOR PAIN , BLEEDING, MIGRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2005: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. UNILATERAL OCCLUSION (LEFT TUBE OCCLUDED). UNSUCCESSFUL OCCLUSION OF RIGHT FALLOPIAN TUBE PLEASE ALSO PROVIDE THE DATE ON WHICH YOU RECEIVED YOUR RESULTS.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: MENORRHAGIA, RASH, DERMATITIS. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA MEDICAL RECORD: DEVICE EXPULSION. LOT NUMBER REPORT (12269948) IS NOT VALID. 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(PRODUCT TECHNICAL COMPLAIN) BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PHYSICAL PAIN/ PAIN/ PELVIC AREA') AND MENORRHAGIA ('ABNORMAL BLEEDING (MENORRHAGIA)') IN A 39-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12269948-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "ABLATION / ON (B)(6) 2005 ESSURE TUBAL STERILIZATION, HYSTEROSCOPY, HYDROTHERMAL ABLATION OF THE ENDOMETRIUM" AND DEVICE INEFFECTIVE "FAILURE TO OCCLUDE FALLOPIAN TUBE(RIGHT SIDE)/HER ESSURE STERILIZATION FAILED ON THE RIGHT SIDE". THE PATIENT'S MEDICAL HISTORY INCLUDED ENDOMETRIAL BIOPSY IN (B)(6) 2005, CRAMP IN LOWER ABDOMEN, ECZEMA, CERVICAL DYSPLASIA, D & C AND LOOP ELECTROSURGICAL EXCISION PROCEDURE. CONCURRENT CONDITIONS INCLUDED HYPERTENSION, MENOMETRORRHAGIA, FACIAL PUFFINESS, PERIORBITAL SWELLING, ITCHING EYES, EYE CRUSTING, HOT FLASHES, BACK PAIN, SPOTTING BETWEEN MENSES, UTERINE BLEEDING, ADENOMYOSIS, UTERINE LEIOMYOMA, FIBROIDS, MENSES IRREGULAR, SKIN SWELLING AND ALLERGIC EXANTHEMA. CONCOMITANT PRODUCTS INCLUDED HYDROCHLOROTHIAZIDE; LISINOPRIL (LISINOPRIL HYDROCHLORTHIAZIDE SANDOZ) SINCE (B)(6) 2004 FOR HYPERTENSION AS WELL AS BETAMETHASONE (CELESTONE), BUPROPION HYDROCHLORIDE (WELLBUTRIN), HYDROCHLOROTHIAZIDE (HYDROTHIAZIDE) AND MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) SINCE (B)(6) 2005. ON (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6) 2005, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 5 MONTHS 8 DAYS AFTER INSERTION OF ESSURE (ESS205). IN (B)(6) 2005, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: MENTAL ANGUISH"). ON (B)(6) 2005, THE PATIENT EXPERIENCED RASH ("RASHES OR SKIN CONDITIONS TYPE: DERMATOSIS/ RASH ON FACE") AND DERMATITIS ("RASHES OR SKIN CONDITIONS - TYPE: DERMATITIS"). ON (B)(6) 2005, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON (B)(6) 2010, THE PATIENT EXPERIENCED DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE, LOCATION UNKNOWN / ESSURE SPRINGS HAVING COME OUT OF HER VAGINA/THERE IS NO ESSURE SPRING IN THE LEFT SIDE."). THE PATIENT WAS TREATED WITH CELECOXIB (CELEXA), DIPHENHYDRAMINE HYDROCHLORIDE, NSAIDS, PARACETAMOL (ACETAMINOPHEN) AND SURGERY (ABLATION ON (B)(6) 2005 / NOVASURE ABLATION AND HYSTERECTOMY WITH SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2010. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING, THE MENORRHAGIA AND VAGINAL HAEMORRHAGE HAD RESOLVED AND THE DEVICE EXPULSION, DEPRESSION, ANXIETY, RASH AND DERMATITIS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DERMATITIS, DEVICE EXPULSION, MENORRHAGIA, PELVIC PAIN, RASH AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: THE ESSURE DEVICE WAS INSERTED ON THE PATIENT'S LEFT AND CONFIRMATION OF PLACEMENT WAS VISUALIZED WITH 0 NUMBER OF COILS VISUALIZED AFTER PLACEMENT. ON PATIENT'S RIGHT THE ESSURE DEVICE WAS INSERTED. THERE WAS A SMALL AMOUNT OF RESISTANCE ON THIS SIDE AND THERE WERE 16 COILS VISUALIZED AFTER PLACEMENT. WHEN SHE WENT TO THE RESTROOM SHE NOTICED A SPRING COIL AND SAVED IT AND HAS BROUGHT IT IN TODAY. IDENTIFICATION OF THE SAMPLE CONFIRMS IT TO BE AN ESSURE SPRING. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2005: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. UNILATERAL OCCLUSION (LEFT TUBE OCCLUDED). UNSUCCESSFUL OCCLUSION OF RIGHT FALLOPIAN TUBE PLEASE ALSO PROVIDE THE DATE ON WHICH YOU RECEIVED YOUR RESULTS. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: MENORRHAGIA, RASH, DERMATITIS. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA MEDICAL RECORD: DEVICE EXPULSION. LOT NUMBER REPORT (12269948) IS INVALID. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-OCT-2019: PFS RECEIVED. EVENTS : ABNORMAL BLEEDING (MENORRHAGIA), ABNORMAL BLEEDING (VAGINAL) OUTCOME UPDATED. NO VALID LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES 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 PELVIC PAIN ('PHYSICAL PAIN/ PAIN/ PELVIC AREA') AND MENORRHAGIA ('ABNORMAL BLEEDING (MENORRHAGIA)') IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12269948) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "FAILURE TO OCCLUDE FALLOPIAN TUBE(RIGHT SIDE)/HER ESSURE STERILIZATION FAILED ON THE RIGHT SIDE" AND MEDICAL DEVICE MONITORING ERROR "ABLATION / ON (B)(6) 2005 ESSURE TUBAL STERILIZATION, HYSTEROSCOPY, HYDROTHERMAL ABLATION OF THE ENDOMETRIUM". THE PATIENT'S MEDICAL HISTORY INCLUDED ENDOMETRIAL BIOPSY IN FEBRUARY 2005, ABDOMINAL PAIN LOWER, ECZEMA, CERVICAL DYSPLASIA, D & C AND LOOP ELECTROSURGICAL EXCISION PROCEDURE. CONCURRENT CONDITIONS INCLUDED HYPERTENSION, MENOMETRORRHAGIA, FACIAL PUFFINESS, PERIORBITAL SWELLING, ITCHING EYES, EYE CRUSTING, HOT FLASHES, BACK PAIN, SPOTTING BETWEEN MENSES, UTERINE BLEEDING, ADENOMYOSIS, UTERINE LEIOMYOMA, FIBROIDS, MENSES IRREGULAR, SKIN SWELLING AND ALLERGIC EXANTHEMA. CONCOMITANT PRODUCTS INCLUDED HYDROCHLOROTHIAZIDE;LISINOPRIL (LISINOPRIL HYDROCHLORTHIAZIDE SANDOZ) SINCE FEBRUARY 2004 FOR HYPERTENSION AS WELL AS BETAMETHASONE (CELESTONE), BUPROPION HYDROCHLORIDE (WELLBUTRIN), HYDROCHLOROTHIAZIDE (HYPOTHIAZIDE) AND MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) SINCE (B)(6) 2005. ON (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON (B)(6) 2005, THE PATIENT EXPERIENCED RASH ("RASHES OR SKIN CONDITIONS TYPE: DERMATITIS/ RASH ON FACE") AND DERMATITIS ("RASHES OR SKIN CONDITIONS - TYPE: DERMATITIS"), 30 DAYS AFTER INSERTION OF ESSURE (ESS205). ON (B)(6) 2005, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON (B)(6) 2010, THE PATIENT EXPERIENCED DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE, LOCATION UNKNOWN / ESSURE SPRINGS HAVING COME OUT OF HER VAGINA/THERE IS NO ESSURE SPRING IN THE LEFT SIDE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: MENTAL ANGUISH"). THE PATIENT WAS TREATED WITH CELECOXIB (CELEXA), DIPHENHYDRAMINE HYDROCHLORIDE, NSAIDS, PARACETAMOL (ACETAMINOPHEN) AND SURGERY (ABLATION ON (B)(6) 2005 / NOVASURE ABLATION AND HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2010. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING AND THE MENORRHAGIA, DEVICE EXPULSION, VAGINAL HAEMORRHAGE, DEPRESSION, ANXIETY, RASH AND DERMATITIS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DERMATITIS, DEVICE EXPULSION, MENORRHAGIA, PELVIC PAIN, RASH AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: THE ESSURE DEVICE WAS INSERTED ON THE PATIENT'S LEFT AND CONFIRMATION OF PLACEMENT WAS VISUALIZED WITH 0 NUMBER OF COILS VISUALIZED AFTER PLACEMENT. ON PATIENT'S RIGHT THE ESSURE DEVICE WAS INSERTED. THERE WAS A SMALL AMOUNT OF RESISTANCE ON THIS SIDE AND THERE WERE 16 COILS VISUALIZED AFTER PLACEMENT. WHEN SHE WENT TO THE RESTROOM SHE NOTICED A SPRING COIL AND SAVED IT AND HAS BROUGHT IT IN TODAY. IDENTIFICATION OF THE SAMPLE CONFIRMS IT TO BE AN ESSURE SPRING. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2005: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. UNILATERAL OCCLUSION (LEFT TUBE OCCLUDED).. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: MENORRHAGIA, RASH, DERMATITIS. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA MEDICAL RECORD: DEVICE EXPULSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PFS AND MR RECEIVED: EVENTS: ABNORMAL BLEEDING (VAGINAL), MENORRHAGIA, DEPRESSION, MENTAL ANGUISH, RASH ON FACE, MIGRATION OF ESSURE DEVICE / FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE, ENDOMETRIAL ABLATION PERFORMED CONCOMITANTLY WITH THE ESSURE MICRO-INSERT IMPLANTATION NOS, DERMATITIS WERE ADDED. EVENT OUTCOME PELVIC PAIN FEMALE WERE CHANGED UNKNOWN TO RECOVERING / RESOLVING. EVENT ONSET DATE WERE ADDED. LAB DATA WERE ADDED. CONCOMITANT DRUGS AND CONDITIONS WERE ADDED. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 538899 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS205 | 12269948-NOT VALID | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Other| R | CELESTONE [BETAMETHASONE]| CELESTONE [BETAMETHASONE]| CELESTONE [BETAMETHASONE]| CELESTONE [BETAMETHASONE]| CELESTONE [BETAMETHASONE]| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| HYDROTHIAZIDE| HYDROTHIAZIDE| HYDROTHIAZIDE| HYDROTHIAZIDE| HYDROTHIAZIDE| LISINOPRIL HYDROCHLORTHIAZIDE SANDOZ| LISINOPRIL HYDROCHLORTHIAZIDE SANDOZ| LISINOPRIL HYDROCHLORTHIAZIDE SANDOZ| LISINOPRIL HYDROCHLORTHIAZIDE SANDOZ| LISINOPRIL HYDROCHLORTHIAZIDE SANDOZ| WELLBUTRIN| WELLBUTRIN| WELLBUTRIN| WELLBUTRIN| WELLBUTRIN| CELESTONE (BETAMETHASONE)| DEPO-PROVERA| HYDROTHIAZIDE| LISINOPRIL HYDROCHLORTHIAZIDE SANDOZ| WELLBUTRIN |