ESSURE
Report
- Report Number
- 2951250-2019-04837
- Event Type
- Injury
- Date Received
- August 16, 2019
- Date of Event
- November 1, 2011
- Report Date
- March 16, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO: 802745) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DIDN¿T UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED DEPRESSION (NOT RECOVERED PRIOR TO ESSURE), SUBCHORIONIC HEMORRHAGE, PREGNANCY, GRAVIDA I, PARITY 1, ELEVATED BP, MIGRAINE HEADACHE, SEIZURES, MULTIPLE GASTRIC ULCERS, YEAST INFECTION, CESAREAN SECTION, EAR OPERATION, CERVIX INFLAMMATION AND CYST OVARY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: PRISTIQ. CONCOMITANT PRODUCTS INCLUDED DESVENLAFAXINE SUCCINATE (PRISTIQ). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ABDOMINAL DISTENSION ("HORMONAL CHANGES DESCRIBE: BLOATING"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)/ EXCESSIVE BLEEDING") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES DESCRIBE: BLOATING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ARTHRALGIA ("JOINTS PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND PAPILLOMA VIRAL INFECTION ("HPV"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED); BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, DYSPAREUNIA, BACK PAIN, ABDOMINAL DISTENSION, HORMONE LEVEL ABNORMAL, DEPRESSION AND PAPILLOMA VIRAL INFECTION OUTCOME WAS UNKNOWN, THE ARTHRALGIA AND ABDOMINAL PAIN WAS RESOLVING AND THE VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ARTHRALGIA, BACK PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, HORMONE LEVEL ABNORMAL, MENORRHAGIA, PAPILLOMA VIRAL INFECTION, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DETAILS - RIGHT 7 COILS AND LEFT 4 COILS WERE SEEN, ON (B)(6) 2011, DATE OF SURGERY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM: ON (B)(6) 2012: IMPRESSION: RADIOGRAPHIC FINDINGS SUGGEST SUCCESSFUL CLOSURE OF THE FALLOPIAN TUBES WITH BILATERAL ESSURE DEVICES. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS:BACK PAIN, DYSMENORRHEA, NAUSEA, DEPRESSION, MENORRHAGIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-JAN-2020: MR RECEIVED- LOT NUMBER WERE ADDED. NEW REPORTER, MEDICAL HISTORY, RACE, LAB DATA 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 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 PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 802745) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DIDN¿T UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED DEPRESSION (NOT RECOVERED PRIOR TO ESSURE), SUBCHORIONIC HEMORRHAGE, GRAVIDA, GRAVIDA I, PARITY 1, ELEVATED BP, MIGRAINE HEADACHE, SEIZURES, MULTIPLE GASTRIC ULCERS, YEAST INFECTION, CESAREAN SECTION, EAR OPERATION, CERVIX INFLAMMATION AND CYST OVARY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: PRISTIQ. CONCOMITANT PRODUCTS INCLUDED DESVENLAFAXINE SUCCINATE (PRISTIQ). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ABDOMINAL DISTENSION ("HORMONAL CHANGES DESCRIBE: BLOATING"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)/ EXCESSIVE BLEEDING") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES DESCRIBE: BLOATING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ARTHRALGIA ("JOINTS PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND PAPILLOMA VIRAL INFECTION ("HPV"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED); BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED IN (B)(6) 2012. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, DYSPAREUNIA, BACK PAIN, ABDOMINAL DISTENSION, HORMONE LEVEL ABNORMAL, DEPRESSION AND PAPILLOMA VIRAL INFECTION OUTCOME WAS UNKNOWN, THE ARTHRALGIA AND ABDOMINAL PAIN WAS RESOLVING AND THE VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ARTHRALGIA, BACK PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, HORMONE LEVEL ABNORMAL, MENORRHAGIA, PAPILLOMA VIRAL INFECTION, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DETAILS - RIGHT 7 COILS AND LEFT 4 COILS WERE SEEN, (B)(6) 2011 DATE OF SURGERY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: IMPRESSION: RADIOGRAPHIC FINDINGS SUGGEST SUCCESSFUL CLOSURE OF THE FALLOPIAN TUBES WITH BILATERAL ESSURE DEVICES. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-FEB-2020: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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 PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ARTHRALGIA ("JOINTS PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND BACK PAIN ("BACK PAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED)). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, DYSPAREUNIA, ARTHRALGIA, ABDOMINAL PAIN AND BACK PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ARTHRALGIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA AND PELVIC PAIN TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-SEP-2019: PFS RECEIVED : EVENTS ADDED- BACK PAIN. ESSURE INSERTION DATE UPDATED. NO LOT NUMBER 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 PELVIC PAIN ('PELVIC PAIN'), MENORRHAGIA ('ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)/ EXCESSIVE BLEEDING') AND VAGINAL HAEMORRHAGE ('ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 802745) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DIDN¿T UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED DEPRESSION (NOT RECOVERED PRIOR TO ESSURE), SUBCHORIONIC HEMORRHAGE, GRAVIDA, GRAVIDA I, PARITY 1, ELEVATED BP, MIGRAINE HEADACHE, SEIZURES, MULTIPLE GASTRIC ULCERS, YEAST INFECTION, CESAREAN SECTION, EAR OPERATION, CERVIX INFLAMMATION AND CYST OVARY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: PRISTIQ. CONCOMITANT PRODUCTS INCLUDED DESVENLAFAXINE SUCCINATE (PRISTIQ). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES DESCRIBE: BLOATING"). IN NOVEMBER 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND ABDOMINAL DISTENSION ("HORMONAL CHANGES DESCRIBE: BLOATING"). IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ARTHRALGIA ("JOINTS PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND PAPILLOMA VIRAL INFECTION ("HPV"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION ON (B)(6) 2012 AND TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED); BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, DYSPAREUNIA, BACK PAIN, ABDOMINAL DISTENSION, HORMONE LEVEL ABNORMAL, DEPRESSION AND PAPILLOMA VIRAL INFECTION OUTCOME WAS UNKNOWN, THE MENORRHAGIA AND VAGINAL HAEMORRHAGE HAD RESOLVED AND THE ARTHRALGIA AND ABDOMINAL PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ARTHRALGIA, BACK PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, HORMONE LEVEL ABNORMAL, MENORRHAGIA, PAPILLOMA VIRAL INFECTION, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DETAILS - RIGHT 7 COILS AND LEFT 4 COILS WERE SEEN. (B)(6) 2011 DATE OF SURGERY: DISCREPANCY NOTED IN ESSURE REMOVAL DATE- (B)(6) 2012 AND (B)(6) 2012. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON 07-FEB-2012: IMPRESSION: RADIOGRAPHIC FINDINGS SUGGEST SUCCESSFUL CLOSURE OF THE FALLOPIAN TUBES WITH BILATERAL ESSURE DEVICES. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-FEB-2020: PLAINTIFF FACT SHEET WAS RECEIVED-ABLATION WAS DONE FOR EVENT- ABNORMAL BLEEDING (VAGINAL), ABNORMAL BLEEDING (MENORRHAGIA) WAS ADDED.REPORTER INFORMATION WERE ADDED. EVENTS ONSET DATE, ESSURE REMOVAL DATE WERE 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 PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DIDN¿T UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED DEPRESSION (NOT RECOVERED PRIOR TO ESSURE). PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: PRISTIQ. CONCOMITANT PRODUCTS INCLUDED DESVENLAFAXINE SUCCINATE (PRISTIQ). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ABDOMINAL DISTENSION ("HORMONAL CHANGES DESCRIBE: BLOATING"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)/ EXCESSIVE BLEEDING") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES DESCRIBE: BLOATING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ARTHRALGIA ("JOINTS PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND PAPILLOMA VIRAL INFECTION ("HPV"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED); BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED IN (B)(6) 2012. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, DYSPAREUNIA, BACK PAIN, ABDOMINAL DISTENSION, HORMONE LEVEL ABNORMAL, DEPRESSION AND PAPILLOMA VIRAL INFECTION OUTCOME WAS UNKNOWN, THE ARTHRALGIA AND ABDOMINAL PAIN WAS RESOLVING AND THE VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ARTHRALGIA, BACK PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, HORMONE LEVEL ABNORMAL, MENORRHAGIA, PAPILLOMA VIRAL INFECTION, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-NOV-2019: PLAINTIFF FACT SHEET RECEIVED : EVENTS ADDED- ABDOMINAL DISTENSION, HORMONE LEVEL ABNORMAL, VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION, HPV ,DEVICE MONITORING PROCEDURE NOT PERFORMED. REMOVAL DATE ADDED. OUTCOME OF EVENTS ¿ARTHRALGIA, ABDOMINAL PAIN¿ UPDATED TO RECOVERING/ RESOLVING. EVENT ONSET DATES UPDATED. NO LOT NUMBER 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 PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ARTHRALGIA ("JOINTS PAIN") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED)). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, DYSPAREUNIA, ARTHRALGIA AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ARTHRALGIA, DYSMENORRHOEA, DYSPAREUNIA AND PELVIC PAIN TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 08/05/2019: PLAINTIFF FACT SHEET RECEIVED. EVENT INJURY WAS DELETED AND DEVICE CATEGORY CHANGED FROM DEVICE OTHER EVENT TO INCIDENT. EVENTS ADDED FROM PFS- DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PELVIC PAIN, ABDOMINAL PAIN, JOINTS PAIN. REPORTER INFORMATION 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 |
|---|---|---|---|---|---|---|---|
| 693974 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 802745 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Other| R | PRISTIQ| PRISTIQ| PRISTIQ| PRISTIQ |