ESSURE
Report
- Report Number
- 2951250-2019-09576
- Event Type
- Injury
- Date Received
- October 7, 2019
- Report Date
- October 29, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- 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. 628058) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED LOOP ELECTROSURGICAL EXCISION PROCEDURE ON (B)(6)2009, DEPRESSION, INGUINAL HERNIA, STRESS URINARY INCONTINENCE, CYSTOSCOPY, CYSTOCELE, URINARY FREQUENCY, UTEROVAGINAL PROLAPSE, UTERINE CERVICAL SQUAMOUS METAPLASIA, ADENOMYOSIS, ABDOMINAL PAIN UPPER, ESOPHAGOGASTRODUODENOSCOPY (MID GASTRITIS WITH ONE TINY NN-BLEEDING EROSION. BX FOR H. PYLORI OBTAINED), GASTRITIS (MID GASTRITIS WITH ONE TINY NN-BLEEDING EROSION), SUBSTERNAL CHEST PAIN, LIVER FUNCTION TESTS RAISED, PELVIC PROLAPSE, PARITY 2 AND GRAVIDA. CONCOMITANT PRODUCTS INCLUDED TOPIRAMATE (TOPAMAX) AND VENLAFAXINE HYDROCHLORIDE (EFFEXOR). ON (B)(6)2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), HYPERSENSITIVITY ("HYPERSENSITIVITY"), BLADDER DISORDER ("BLADDER PROBS."), MIGRAINE ("MIGRAINE/ HEADACHES"), TOOTH DISORDER ("DENTAL PROBS."), FATIGUE ("FATIGUE") AND NAUSEA ("NAUSEA"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6)2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, ABDOMINAL PAIN, BLADDER DISORDER, MIGRAINE, TOOTH DISORDER, FATIGUE AND NAUSEA HAD RESOLVED AND THE HYPERSENSITIVITY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BLADDER DISORDER, DYSMENORRHOEA, FATIGUE, HYPERSENSITIVITY, MIGRAINE, NAUSEA, PELVIC PAIN AND TOOTH DISORDER TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RECEIVED TREATMENT FOR DYSMENORRHEA, PELVIC PAIN, ABDOMINAL PAIN, HYPERSENSITIVITY, BLADDER PROBLEM, MIGRAINE, DENTAL PROBLEM, FATIGUE, NAUSEA, DATE OF ADDITIONAL SURGERIES-(B)(6)2015 DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6)2009: TOTAL BILATERAL OCCLUSION. IMAGING PROCEDURE - ON (B)(6)2009: ESSURE CONFIRMATION TEST(S)(UNSPECIFIED) : RESULT-BILATERAL OCCLUSION. LOT NUMBER: 628058 MANUFACTURING DATE: 2008/09 EXPIRATION DATE: 2010/09. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-OCT-2019: 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, 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. 628058) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED LOOP ELECTROSURGICAL EXCISION PROCEDURE ON (B)(6) 2009, DEPRESSION, INGUINAL HERNIA, STRESS URINARY INCONTINENCE, CYSTOSCOPY, CYSTOCELE, URINARY FREQUENCY, VAGINAL PROLAPSE, UTERINE CERVICAL METAPLASIA, ADENOMYOSIS, ABDOMINAL PAIN UPPER, ESOPHAGOGASTRODUODENOSCOPY (MID GASTRITIS WITH ONE TINY NN-BLEEDING EROSION. BX FOR H. PYLORI OBTAINED), GASTRITIS (MID GASTRITIS WITH ONE TINY NN-BLEEDING EROSION), SUBSTERNAL CHEST PAIN, FUNCTION LIVER ABNORMAL, PELVIC PROLAPSE, PARITY 2 AND GRAVIDA. CONCOMITANT PRODUCTS INCLUDED TOPIRAMATE (TOPAMAX) AND VENLAFAXINE HYDROCHLORIDE (EFFEXOR). ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), HYPERSENSITIVITY ("HYPERSENSITIVITY"), BLADDER DISORDER ("BLADDER PROBS."), MIGRAINE ("MIGRAINE/ HEADACHES"), TOOTH DISORDER ("DENTAL PROBS."), FATIGUE ("FATIGUE") AND NAUSEA ("NAUSEA"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, ABDOMINAL PAIN, BLADDER DISORDER, MIGRAINE, TOOTH DISORDER, FATIGUE AND NAUSEA HAD RESOLVED AND THE HYPERSENSITIVITY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BLADDER DISORDER, DYSMENORRHOEA, FATIGUE, HYPERSENSITIVITY, MIGRAINE, NAUSEA, PELVIC PAIN AND TOOTH DISORDER TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RECEIVED TREATMENT FOR DYSMENORRHEA, PELVIC PAIN, ABDOMINAL PAIN, HYPERSENSITIVITY, BLADDER PROBLEM, MIGRAINE, DENTAL PROBLEM, FATIGUE, NAUSEA, DATE OF ADDITIONAL SURGERIES (B)(6) 2015. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2009: TOTAL BILATERAL OCCLUSION. IMAGING PROCEDURE - ON (B)(6) 2009: ESSURE CONFIRMATION TEST(S)(UNSPECIFIED) : RESULT-BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-SEP-2019: PLAINTIFF FACT SHEET AND MEDICAL RECORD RECEIVED. PATIENT DEMOGRAPHIC ADDED. MEDICAL HISTORY, LOT NUMBER AND LAB DATA WERE ADDED. INCIDENT: 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.
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) 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), HYPERSENSITIVITY ("HYPERSENSITIVITY"), BLADDER DISORDER ("BLADDER PROBS."), MIGRAINE ("MIGRAINE"), TOOTH DISORDER ("DENTAL PROBS."), FATIGUE ("FATIGUE") AND NAUSEA ("NAUSEA"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, ABDOMINAL PAIN, BLADDER DISORDER, MIGRAINE, TOOTH DISORDER, FATIGUE AND NAUSEA HAD RESOLVED AND THE HYPERSENSITIVITY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BLADDER DISORDER, DYSMENORRHOEA, FATIGUE, HYPERSENSITIVITY, MIGRAINE, NAUSEA, PELVIC PAIN AND TOOTH DISORDER TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RECEIVED TREATMENT FOR DYSMENORRHEA, PELVIC PAIN, ABDOMINAL PAIN, HYPERSENSITIVITY, BLADDER PROBLEM, MIGRAINE, DENTAL PROBLEM, FATIGUE, NAUSEA, DATE OF ADDITIONAL SURGERIES (B)(6) 2015. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE ON (B)(6) 2009: ESSURE CONFIRMATION TEST(S)(UNSPECIFIED) : RESULT BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-SEP-2019: PFS RECEIVED : LAWYER WAS ADDED. CASE BECOME INCIDENT PREVIOUSLY ADDED INJURY NOS WAS REPLACED WITH DYSMENORRHEA AND NEW EVENTS : PELVIC PAIN, ABDOMINAL PAIN, HYPERSENSITIVITY, BLADDER PROBLEM, MIGRAINE, DENTAL PROBLEM, FATIGUE, NAUSEA, WERE ADDED. LAB DATA WAS 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 956437 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 628058 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R | EFFEXOR| EFFEXOR| TOPAMAX| TOPAMAX |