ESSURE
Report
- Report Number
- 2951250-2019-06910
- Event Type
- Injury
- Date Received
- September 18, 2019
- Date of Event
- September 1, 2011
- Report Date
- March 20, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, 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. 841528) 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 "DID NOT UNDERGO CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED ASTHMA AND VERTIGO. CONCOMITANT PRODUCTS INCLUDED NSAIDS FROM (B)(6) 2011 TO (B)(6) 2019 AND PARACETAMOL (ACETAMINOPHEN) FROM (B)(6) 2011 TO (B)(6) 2019. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN") AND BACK PAIN ("LOW BACK PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA AND VAGINAL HAEMORRHAGE HAD RESOLVED, THE DEPRESSION, ANXIETY AND DYSMENORRHOEA OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN LOWER AND BACK PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANXIETY, BACK PAIN, DEPRESSION, DYSMENORRHOEA, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN DATE OF INSERTION- (B)(6) 2011, (B)(6) 2011. PATIENT RECEIVED TREATMENT FOR EVENTS ¿ABDOMINAL PAIN, PELVIC PAIN, MENORRHAGIA. ONE COIL WAS NOTED ON THE OUTSIDE OF THE OSTIUM. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-FEB-2020: PLAINTIFF FACT SHEET AND MEDICAL RECORDS RECEIVED. LOT NUMBER ADDED. EVENTS ADDED FROM PFS- ABNORMAL BLEEDING (VAGINAL), DYSMENORRHEA (CRAMPING), DID NOT UNDERGO CONFIRMATION TEST, LOWER ABDOMINAL PAIN, LOW BACK PAIN. EVENT PSYCH INJURY WAS UPDATED TO PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION AND MENTAL ANGUISH. REPORTER INFORMATION, AKA NAME, CONCOMITANT DRUG WERE ADDED. ONSET DATE OF EVENT MENORRHAGIA, PELVIC PAIN 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 (BATCH NO. 841528) 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 "DID NOT UNDERGO CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED ASTHMA AND VERTIGO. CONCOMITANT PRODUCTS INCLUDED NSAIDS FROM (B)(6) 2011 TO (B)(6) 2019 AND PARACETAMOL (ACETAMINOPHEN) FROM (B)(6) 2011 TO (B)(6) 2019. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN") AND BACK PAIN ("LOW BACK PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA AND VAGINAL HAEMORRHAGE HAD RESOLVED, THE DEPRESSION, ANXIETY AND DYSMENORRHOEA OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN LOWER AND BACK PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANXIETY, BACK PAIN, DEPRESSION, DYSMENORRHOEA, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN DATE OF INSERTION- (B)(6) 2011, (B)(6) 2011 PATIENT RECEIVED TREATMENT FOR EVENTS ¿ABDOMINAL PAIN, PELVIC PAIN, MENORRHAGIA. ONE COIL WAS NOTED ON THE OUTSIDE OF THE OSTIUM. LOT NUMBER: 841528, MANUFACTURE DATE: 2011-03, EXPIRATION DATE: 2014-03. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-MAR-2020: QUALITY SAFETY EVALUATION OF PTC. 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. 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), ABDOMINAL PAIN ("ABDOMINAL PAIN"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY") AND MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"). THE PATIENT WAS TREATED WITH SURGERY (HYST. (FULL),SALPING. (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN AND MENORRHAGIA HAD RESOLVED AND THE PSYCHOLOGICAL TRAUMA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, MENORRHAGIA, PELVIC PAIN AND PSYCHOLOGICAL TRAUMA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN DATE OF INSERTION- (B)(6) 2011, (B)(6) 2011 PATIENT RECEIVED TREATMENT FOR EVENTS ¿ABDOMINAL PAIN, PELVIC PAIN, MENORRHAGIA . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-SEP-2019: PFS RECEIVED-EVENT INJURY UPDATED TO PELVIC PAIN. NEW EVENTS ABDOMINAL PAIN, PSYCH INJURY, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING) WERE ADDED. OUTCOME OF PELVIC PAIN UPDATE TO RECOVERED / RESOLVED. PATIENT 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 INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 874649 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 841528 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Other| R | ACETAMINOPHEN| ACETAMINOPHEN| NSAIDS| NSAIDS |