ESSURE
Report
- Report Number
- 2951250-2019-04074
- Event Type
- Injury
- Date Received
- July 22, 2019
- Date of Event
- September 1, 2008
- Report Date
- November 6, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ('ABDOMINAL PAIN'), DEVICE EXPULSION ('MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS') AND SYSTEMIC LUPUS ERYTHEMATOSUS ('AUTOIMMUNE DISORDER TYPE OF DISORDER: POSSIBLE LUPUS') IN A 43-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: ESSURE CONFIRMATION TEST(S) CONDUCTED, SPECIFY: (B)(6)2008. TYPE OF TEST: - I DON'T RECALL. RESULT: TOTAL BILATERAL OCCLUSION. THE COILS WERE IN PLACE. CONCURRENT CONDITIONS INCLUDED OBESITY. CONCOMITANT PRODUCTS INCLUDED DULOXETINE HYDROCHLORIDE (CYMBALTA) SINCE 2019, FENTANYL CITRATE (NARCO) SINCE 2008, LAMOTRIGINE SINCE 2008, MAGNESIUM OXIDE SINCE 2018, TIZANIDINE SINCE 2018, TRAZODONE HYDROCHLORIDE (TRAZODONE HCL) SINCE 2008 AND VITAMIN D NOS (VITAMIN D) SINCE 2008. ON (B)(6)2008, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)2008, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("LOWER BACK PAIN"), CYSTITIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI"), VULVOVAGINAL MYCOTIC INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), FATIGUE ("FATIGUE"), NAUSEA ("NAUSEA") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6)2009, THE PATIENT EXPERIENCED POST-TRAUMATIC STRESS DISORDER ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: PTSD"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ALOPECIA ("HAIR LOSS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE/ WEIGHT GAIN"). IN (B)(6)2010, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS"). IN (B)(6)2017, THE PATIENT EXPERIENCED SPLENIC LESION ("OTHER INJURY (IES) OR COMPLICATION PLEASE DESCRIBE: LESIONS ON SPLEEN"). ON (B)(6)2017, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 8 YEARS 8 MONTHS AFTER INSERTION OF ESSURE. IN 2017, THE PATIENT EXPERIENCED RASH ("RASHES OR SKIN CONDITIONS TYPE: RASHES,"). IN (B)(6)2017, THE PATIENT EXPERIENCED SYSTEMIC LUPUS ERYTHEMATOSUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6)2019, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FEELING ABNORMAL ("BRAIN FOG"), OVARIAN DISORDER ("SCAR TISSUE BUILT UP ON MY OVARIES"), DYSMENORRHOEA ("DYSMENNORHEA (CRAMPING)"), HYPERSENSITIVITY ("ALLERGY"), MIGRAINE ("MIGRAINE") AND HEADACHE ("HEADACHE"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES), AND HYSTERECTOMY PARTIAL, SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE WAS REMOVED ON (B)(6)2019. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, DEVICE EXPULSION, SYSTEMIC LUPUS ERYTHEMATOSUS, VULVOVAGINAL MYCOTIC INFECTION, FEMALE SEXUAL DYSFUNCTION, POST-TRAUMATIC STRESS DISORDER, ANXIETY, DEPRESSION, BLADDER DISORDER, URINARY TRACT DISORDER, TOOTH DISORDER, SPLENIC LESION, NAUSEA, OVARIAN DISORDER AND HYPERSENSITIVITY OUTCOME WAS UNKNOWN, THE VAGINAL HAEMORRHAGE AND FEELING ABNORMAL WAS RESOLVING AND THE MENORRHAGIA, BACK PAIN, CYSTITIS, URINARY TRACT INFECTION, RASH, FATIGUE, WEIGHT INCREASED, ALOPECIA, DYSPAREUNIA, DYSMENORRHOEA, MIGRAINE AND HEADACHE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANXIETY, BACK PAIN, BLADDER DISORDER, CYSTITIS, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, FEMALE SEXUAL DYSFUNCTION, HEADACHE, HYPERSENSITIVITY, MENORRHAGIA, MIGRAINE, NAUSEA, OVARIAN DISORDER, POST-TRAUMATIC STRESS DISORDER, RASH, SPLENIC LESION, SYSTEMIC LUPUS ERYTHEMATOSUS, TOOTH DISORDER, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VULVOVAGINAL MYCOTIC INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED: DATE(S) OF INSERTION: (B)(6)2008, (B)(6)2008, (B)(6)2008. CURRENT WEIGHT 251 LBS. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 213 LBS. PATIENT RECEIVED TREATMENT FOR : PAIN, BLEEDING, MIGRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 32 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6)2008: RESULT: TOTAL BILATERAL OCCLUSION. THE COILS WERE IN PLACE. IMAGING PROCEDURE - ON (B)(6)2008: ESSURE CONFIRMATION TEST(S) (UNSPECIFIED) BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-OCT-2019: PFS RECEIVED. EVENT AUTOIMMUNE DISORDER UPDATED TO AUTOIMMUNE DISORDER TYPE OF DISORDER: POSSIBLE LUPUS, MIGRATION OF DEVICE UPDATED TO PARTIAL EXPULSION OF DEVICE. ONSET DATES FOR EVENTS WERE UPDATED. OUTCOME FOR RASH, BLADDER INFECTION AND UTI WAS UPDATED FROM UNKNOWN TO RECOVERED/RESOLVED. LAB DATA ADDED. NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. 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 ABDOMINAL PAIN ('ABDOMINAL PAIN'), DEVICE DISLOCATION ('MIGRATION') AND AUTOIMMUNE DISORDER ('AUTOIMMUNE DISORDER') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: ESSURE CONFIRMATION TEST(S) CONDUCTED, SPECIFY: (B)(6) 2008 TYPE OF TEST: I DON'T RECALL RESULT: TOTAL BILATERAL OCCLUSION THE COILS WERE IN PLACE. CONCURRENT CONDITIONS INCLUDED OBESITY. CONCOMITANT PRODUCTS INCLUDED DULOXETINE HYDROCHLORIDE (CYMBALTA) SINCE 2019, FENTANYL CITRATE (NARCO) SINCE 2008, LAMOTRIGINE SINCE 2008, MAGNESIUM OXIDE SINCE 2018, TIZANIDINE SINCE 2018, TRAZODONE HYDROCHLORIDE (TRAZODONE HCL) SINCE 2008 AND VITAMIN D NOS (VITAMIN D) SINCE 2008. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2008, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), BACK PAIN ("LOWER BACK PAIN"), CYSTITIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE"), VULVOVAGINAL MYCOTIC INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), FATIGUE ("FATIGUE"), NAUSEA ("NAUSEA") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2009, THE PATIENT EXPERIENCED POST-TRAUMATIC STRESS DISORDER ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: PTSD"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ALOPECIA ("HAIR LOSS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE/ WEIGHT GAIN"). IN 2010, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS"). IN 2017, THE PATIENT EXPERIENCED AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND RASH ("*RASHES OR SKIN CONDITIONS TYPE:,"). IN 2018, THE PATIENT EXPERIENCED SPLENIC LESION ("OTHER INJURY (IES) OR COMPLICATION PLEASE DESCRIBE: LESIONS ON SPLEEN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"), FEELING ABNORMAL ("BRAIN FOG"), OVARIAN DISORDER ("SCAR TISSUE BUILT UP ON MY OVARIES"), DYSMENORRHOEA ("DYSMENNORHEA (CRAMPING)"), HYPERSENSITIVITY ("ALLERGY"), MIGRAINE ("MIGRAINE") AND HEADACHE ("HEADACHE"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES), AND HYSTRECTOMY PARTIAL, SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, DEVICE DISLOCATION, AUTOIMMUNE DISORDER, CYSTITIS, URINARY TRACT INFECTION, VULVOVAGINAL MYCOTIC INFECTION, FEMALE SEXUAL DYSFUNCTION, POST-TRAUMATIC STRESS DISORDER, ANXIETY, DEPRESSION, RASH, BLADDER DISORDER, URINARY TRACT DISORDER, TOOTH DISORDER, SPLENIC LESION, NAUSEA, OVARIAN DISORDER AND HYPERSENSITIVITY OUTCOME WAS UNKNOWN, THE VAGINAL HAEMORRHAGE AND FEELING ABNORMAL WAS RESOLVING AND THE MENORRHAGIA, BACK PAIN, FATIGUE, WEIGHT INCREASED, ALOPECIA, DYSPAREUNIA, DYSMENORRHOEA, MIGRAINE AND HEADACHE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANXIETY, AUTOIMMUNE DISORDER, BACK PAIN, BLADDER DISORDER, CYSTITIS, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, FEMALE SEXUAL DYSFUNCTION, HEADACHE, HYPERSENSITIVITY, MENORRHAGIA, MIGRAINE, NAUSEA, OVARIAN DISORDER, POST-TRAUMATIC STRESS DISORDER, RASH, SPLENIC LESION, TOOTH DISORDER, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VULVOVAGINAL MYCOTIC INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED: DATE(S) OF INSERTION: (B)(6) 2008, (B)(6) 2008, (B)(6) 2008 CURRENT WEIGHT 251 LBS. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 213 LBS. PATIENT RECEIVED TREATMENT FOR : PAIN, BLEEDING, MIGRATION DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 32 KG/SQM. IMAGING PROCEDURE - ON (B)(6) 2008: ESSURE CONFIRMATION TEST(S) (UNSPECIFIED) BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PFS RECEIVED. NEW EVENTS:" DYSMENORRHEA (CRAMPING), ALLERGY, MIGRATION, MIGRAINE, HEADACHE "WERE ADDED. OUTCOME FOR PREVIOUSLY REPORTED EVENTS DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), BACK PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), FATIGUE, HAIR LOSS IS UPDATED TO RECOVERED / RESOLVED NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. 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 ABDOMINAL PAIN ('ABDOMINAL PAIN') AND AUTOIMMUNE DISORDER ('AUTOIMMUNE DISORDER') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: ESSURE CONFIRMATION TEST(S) CONDUCTED, SPECIFY: (B)(6) 2008. TYPE OF TEST: - I DON'T RECALL. RESULT: TOTAL BILATERAL OCCLUSION. THE COILS WERE IN PLACE. CONCURRENT CONDITIONS INCLUDED OBESITY. CONCOMITANT PRODUCTS INCLUDED DULOXETINE HYDROCHLORIDE (CYMBALTA) SINCE 2019, FENTANYL CITRATE (NARCO) SINCE 2008, LAMOTRIGINE SINCE 2008, MAGNESIUM OXIDE SINCE 2018, TIZANIDINE SINCE 2018, TRAZODONE HYDROCHLORIDE (TRAZODONE HCL) SINCE 2008 AND VITAMIN D NOS (VITAMIN D) SINCE 2008. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2008, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), BACK PAIN ("LOWER BACK PAIN"), CYSTITIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE"), VULVOVAGINAL MYCOTIC INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), FATIGUE ("FATIGUE"), NAUSEA ("NAUSEA") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2009, THE PATIENT EXPERIENCED POST-TRAUMATIC STRESS DISORDER ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: PTSD"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), WEIGHT FLUCTUATION ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE") AND ALOPECIA ("HAIR LOSS"). IN 2010, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS"). IN 2017, THE PATIENT EXPERIENCED AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND RASH ("*RASHES OR SKIN CONDITIONS TYPE:,"). IN 2018, THE PATIENT EXPERIENCED SPLENIC LESION ("OTHER INJURY (IES) OR COMPLICATION PLEASE DESCRIBE: LESIONS ON SPLEEN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"), FEELING ABNORMAL ("BRAIN FOG") AND SCAR ("SCAR TISSUE BUILT UP ON MY OVARIES"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, AUTOIMMUNE DISORDER, BACK PAIN, CYSTITIS, URINARY TRACT INFECTION, VULVOVAGINAL MYCOTIC INFECTION, FEMALE SEXUAL DYSFUNCTION, POST-TRAUMATIC STRESS DISORDER, ANXIETY, DEPRESSION, RASH, BLADDER DISORDER, URINARY TRACT DISORDER, TOOTH DISORDER, FATIGUE, WEIGHT FLUCTUATION, ALOPECIA, SPLENIC LESION, NAUSEA, DYSPAREUNIA AND SCAR OUTCOME WAS UNKNOWN AND THE VAGINAL HAEMORRHAGE, MENORRHAGIA AND FEELING ABNORMAL WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANXIETY, AUTOIMMUNE DISORDER, BACK PAIN, BLADDER DISORDER, CYSTITIS, DEPRESSION, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, FEMALE SEXUAL DYSFUNCTION, MENORRHAGIA, NAUSEA, POST-TRAUMATIC STRESS DISORDER, RASH, SCAR, SPLENIC LESION, TOOTH DISORDER, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VULVOVAGINAL MYCOTIC INFECTION AND WEIGHT FLUCTUATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED: DATE(S) OF INSERTION: (B)(6) 2008, (B)(6) 2008. CURRENT WEIGHT (B)(6). APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT (B)(6). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 32 KG/SQM. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-JUL-2019: NEW PFS RECEIVED. EVENT INJURY WAS UPDATED AND NEW EVENTS: ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE:, APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE), PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: PTSD, ANXIETY, DEPRESSION, AUTOIMMUNE DISORDER TYPE OF DISORDER:, RASHES OR SKIN CONDITIONS TYPE:, BLADDER OR URINARY PROBLEMS OR CHANGES, DENTAL PROBLEMS, FATIGUE, WEIGHT GAIN / LOSS SPECIFY WHICH ONE:, HAIR LOSS, OTHER INJURY (IES) OR COMPLICATION PLEASE DESCRIBE: LESIONS ON SPLEEN, NAUSEA, DYSPAREUNIA, LOWER BACK PAIN, ABDOMINAL PAIN, BRAIN FOG, BLEEDING, SCAR TISSUE BUILT UP ON MY OVARIES WERE ADDED. CASE BECOMES VALID. REMOVAL DETAILS ADDED, NEW REPORTER AND PLAINTIFFS INFORMATION ADDED. CONCOMITANT DRUGS AND PATIENT NOTES WERE ADDED. INCIDENT: NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 607375 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Other| R | CYMBALTA| CYMBALTA| CYMBALTA| LAMOTRIGINE| LAMOTRIGINE| LAMOTRIGINE| MAGNESIUM OXIDE| MAGNESIUM OXIDE| MAGNESIUM OXIDE| NARCO| NARCO| NARCO| TIZANIDINE| TIZANIDINE| TIZANIDINE| TRAZODONE HCL| TRAZODONE HCL| TRAZODONE HCL| VITAMIN D [VITAMIN D NOS]| VITAMIN D [VITAMIN D NOS]| VITAMIN D [VITAMIN D NOS]| CYMBALTA| LAMOTRIGINE| MAGNESIUM OXIDE| NARCO| TIZANIDINE| TRAZODONE HCL| VITAMIN D [VITAMIN D NOS] |