ESSURE
Report
- Report Number
- 2951250-2020-08071
- Event Type
- Injury
- Date Received
- May 21, 2020
- Report Date
- May 20, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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. 880435) INSERTED FOR FEMALE STERILISATION. 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 PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), GENITAL HAEMORRHAGE ("GEN. ABNORM. BLEED"), DERMATITIS ALLERGIC ("RASH/SKIN CONDITIONS"), POST PROCEDURAL COMPLICATION ("POST REMOVAL COMPLICATION") AND HYPERSENSITIVITY ("ALLERGIC REACTION"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, GENITAL HAEMORRHAGE AND DERMATITIS ALLERGIC HAD RESOLVED AND THE PSYCHOLOGICAL TRAUMA, POST PROCEDURAL COMPLICATION AND HYPERSENSITIVITY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, DERMATITIS ALLERGIC, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, PELVIC PAIN, POST PROCEDURAL COMPLICATION AND PSYCHOLOGICAL TRAUMA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR EVENTS ¿ PELVIC PAIN , ABDOMINAL PAIN , BACK PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PIF WAS RECEIVED. LOT NUMBER WERE ADDED. EVENT ADDED FROM PFS- ALLERGIC REACTION. 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. 880435) 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 "NOVASURE ENDOMETRIAL ABLATION". THE PATIENT'S MEDICAL HISTORY INCLUDED RIGHT LOWER QUADRANT PAIN, NAUSEA, ABDOMINAL DISCOMFORT, VOMITING, DIARRHEA, GASTROENTERITIS, ANXIETY, TONSILLECTOMY, OVARIAN CYST, CHEST PAIN, GESTATIONAL HYPERTENSION, TOBACCO ABUSE, ENDOMETRIOSIS, HEADACHE, NAUSEA, OBESITY, SWEATING ABNORMAL, ABDOMINAL PAIN, CHRONIC CHOLECYSTITIS, FEVER, CHILLS, FATIGUE, EAR PAIN, SORE THROAT, SHORTNESS OF BREATH, COUGH RESEMBLING ASTHMA, PALPITATIONS, BREAST MASS, BREAST PAIN, BREAST DISCHARGE, CONSTIPATION, PAINFUL URINATION, BLOOD IN URINE, INCONTINENCE OF URINE, IRREGULAR PERIODS, PAINFUL PERIODS, PAINFUL INTERCOURSE, HOT FLASHES, VAGINAL DRYNESS, PAP SMEAR ABNORMAL, VAGINAL DISCHARGE, EXCESSIVE THIRST, COLD INTOLERANCE, HEAT INTOLERANCE, WEIGHT GAIN, WEIGHT LOSS, BACK PAIN, NECK PAIN, JOINT PAIN, SKIN RASH, MOLE CHANGES, FREQUENT HEADACHES, DEPRESSION, SLEEP DISORDER, CORPUS LUTEUM CYST, GERD, GRAVIDA II, PARITY 2, PRE-ECLAMPSIA, UMBILICAL HERNIA AND MENORRHAGIA. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MORPHINE, PHENERGAN, TYLENOL, NSAIDS, AND ASPIRIN. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), GENITAL HAEMORRHAGE ("GEN. ABNORM. BLEED"), DERMATITIS ALLERGIC ("RASH/SKIN CONDITIONS"), POST PROCEDURAL COMPLICATION ("POST REMOVAL COMPLICATION") AND HYPERSENSITIVITY ("ALLERGIC REACTION"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC BILATERAL SALPINGECTOMY AND OVARIAN CYSTECTOMY WITH REMOVAL OF CYSTS AND ESSURE COILS.). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, GENITAL HAEMORRHAGE AND DERMATITIS ALLERGIC HAD RESOLVED AND THE PSYCHOLOGICAL TRAUMA, POST PROCEDURAL COMPLICATION AND HYPERSENSITIVITY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, DERMATITIS ALLERGIC, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, PELVIC PAIN, POST PROCEDURAL COMPLICATION AND PSYCHOLOGICAL TRAUMA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED : WAS ESSURE USED IN CONJUNCTION WITH ANY OTHER DATE IS (B)(6) 2012, WHEREAS THE ABLATION WAS PERFORMED WITH ESSURE INSERTION. PATIENT RECEIVED TREATMENT FOR EVENTS ¿ PELVIC PAIN , ABDOMINAL PAIN , BACK PAIN LEFT: COILS WERE RELEASED WITH APPROXIMATELY 3 SHOWN; RIGHT: FOUR WERE VISIBLE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM PELVIS - ON (B)(6) 2018: IMPRESSION: APPENDIX NORMAL, NO OVARIAN ENLARGEMENT, OCCLUSIVE DEVICE WITHIN MEDIAL PORTION OF RIGHT FALLOPIAN TUBE AND LEFT FALLOPIAN TUBE, AND UMBILICAL HERNIA CONTAINING ONLY FAT. LOT NUMBER:880435 MANUFACTURING DATE: 2011-07 EXPIRATION DATE:2014-07. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE IS CONFIRMED IN PATIENTS¿ MEDICAL RECORDS:MEDICAL DEVICE MONITORING ERROR . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-MAY-2021: MR RECEIVED: EVENT NOVASURE ENDOMETRIAL ABLATION PERFORMED ON THE SAME DATE OF ESSURE INSERTION ADDED. REPORTER, MEDICAL HISTORY, HISTORICAL DRUG AND RCC 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. 880435) INSERTED FOR FEMALE STERILISATION. 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 PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), GENITAL HAEMORRHAGE ("GEN. ABNORM. BLEED"), DERMATITIS ALLERGIC ("RASH/SKIN CONDITIONS"), POST PROCEDURAL COMPLICATION ("POST REMOVAL COMPLICATION") AND HYPERSENSITIVITY ("ALLERGIC REACTION"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY BILATERAL). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, GENITAL HAEMORRHAGE AND DERMATITIS ALLERGIC HAD RESOLVED AND THE PSYCHOLOGICAL TRAUMA, POST PROCEDURAL COMPLICATION AND HYPERSENSITIVITY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, DERMATITIS ALLERGIC, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, PELVIC PAIN, POST PROCEDURAL COMPLICATION AND PSYCHOLOGICAL TRAUMA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR EVENTS: PELVIC PAIN , ABDOMINAL PAIN , BACK PAIN. LOT NUMBER:880435 ,MANUFACTURING DATE: 2011-07, & EXPIRATION DATE:2014-07 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-JUN-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) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), GENITAL HAEMORRHAGE ("GEN. ABNORM. BLEED"), DERMATITIS ALLERGIC ("RASH/SKIN CONDITIONS") AND POST PROCEDURAL COMPLICATION ("POST REMOVAL COMPLICATION"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, GENITAL HAEMORRHAGE AND DERMATITIS ALLERGIC HAD RESOLVED AND THE PSYCHOLOGICAL TRAUMA AND POST PROCEDURAL COMPLICATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, DERMATITIS ALLERGIC, GENITAL HAEMORRHAGE, PELVIC PAIN, POST PROCEDURAL COMPLICATION AND PSYCHOLOGICAL TRAUMA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR EVENTS ¿ PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-MAY-2020: PFS RECEIVED-EVENT INJURY UPDATED TO PELVIC PAIN. NEW EVENTS ABDOMINAL PAIN , BACK PAIN, GENERAL. ABNORMAL. BLEEDING ,PSYCH INJURY, POST REMOVAL COMPLICATION, RASH/SKIN CONDITIONS WERE ADDED. OUTCOME OF PELVIC PAIN UPDATED TO RECOVERED / RESOLVED, NEW REPORTER WERE ADDED. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 542043 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 880435 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |