ESSURE
Report
- Report Number
- 2951250-2017-07573
- Event Type
- Injury
- Date Received
- November 23, 2017
- Date of Event
- July 1, 2011
- Report Date
- June 21, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER
Narratives
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW5043446) ON (B)(6) 2015. THE MOST RECENT INFORMATION WAS RECEIVED ON (B)(6) 2019. QUALITY-SAFETY EVALUATION OF PTC: FINAL ASSESSMENT: SINCE NO PRODUCT WAS RETURNED TO US FOR INVESTIGATION, WE WERE UNABLE TO PERFORM AN INVESTIGATION OF THE ACTUAL DEVICE INVOLVED IN THIS COMPLAINT. TYPICALLY, WE WOULD INSPECT THE MICRO-INSERT TO LOOK FOR ANY MANUFACTURING DEFICIENCIES. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. MEDICAL ASSESSMENT: THIS PTC WAS INITIATED DUE TO A REQUEST FOR CONFIRMATION OF QUALITY. THE REPORTED ADVERSE EVENTS CONSIDERED RELATED ARE KNOWN POSSIBLE UNDESIRABLE EVENTS AND NOT INDICATIVE OF A QUALITY DEFICIT PER SE. NO BATCH NUMBER WAS REPORTED. WITHOUT THIS INFORMATION NO BATCH SIGNAL CLUSTER REVIEW IN THE GPV DATABASE FOR A MORE DETAILED STATISTICAL MEDICAL EVALUATION IS POSSIBLE. NEITHER BATCH NUMBER NOR COMPLAINT SAMPLE WERE AVAILABLE FOR FURTHER TECHNICAL INVESTIGATION. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. IN SUMMARY, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT BASED ON THIS REPORT. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN/ PELVIC PAIN'), NEPHROLITHIASIS ('KIDNEY STONES') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING') 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. THE PATIENT'S MEDICAL HISTORY INCLUDED OVERWEIGHT, HYPERPLASIA, ASTHMA AND NAUSEA. CONCURRENT CONDITIONS INCLUDED KIDNEY STONES, UTERINE FIBROID, ENDOMETRIAL HYPERPLASIA, DYSFUNCTIONAL UTERINE BLEEDING, PERINEAL PAIN, NABOTHIAN CYST, UTERINE LEIOMYOMA, FLATUS AND BIOPSY OF BREAST. 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) AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2011, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("INTERCOURSE/ DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE"), URINARY TRACT INFECTION ("INFECTION: BLADDER AND UTIS") AND CYSTITIS ("BLADDER INFECTION"). IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, );") AND MENORRHAGIA ("MENORRHAGIA"). IN 2013, THE PATIENT EXPERIENCED HYPOAESTHESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS: NUMBNESS IN ARMS") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN JANUARY 2015, THE PATIENT EXPERIENCED ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: ANXIETY") AND DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: DEPRESSION"). IN MAY 2015, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN 2017, THE PATIENT EXPERIENCED ASTIGMATISM ("VISION/EYE PROBLEMS ASTIGMATISM"), TOOTH FRACTURE ("DENTAL PROBLEMS, CRACKING TEETH") AND HYPERAESTHESIA TEETH ("DENTLA PROBLEMS SENSITIVITY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED NEPHROLITHIASIS (SERIOUSNESS CRITERION HOSPITALIZATION), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FATIGUE ("FATIGUE"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), INSOMNIA ("INSOMNIA"), ABDOMINAL DISTENSION ("BLOATING"), HYPERSENSITIVITY ("ALLERGIC REACTIONS"), HEADACHE ("HEADACHES"), MASS ("RASHES OR SKIN CONDITIONS: BUMPS"), DRY SKIN ("DRY SKIN"), MIGRAINE ("MIGRAINES"), BACK PAIN ("BACK"), ABDOMINAL PAIN LOWER ("LOWER ABDOMEN") AND CYST ("HEAVY PERIOD AND CYST") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("FIBROIDS"). THE PATIENT WAS TREATED WITH ANTIBIOTICS, IBUPROFEN AND SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6)2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, NEPHROLITHIASIS, GENITAL HAEMORRHAGE, FATIGUE, ABDOMINAL PAIN, INSOMNIA, ABDOMINAL DISTENSION, HYPERSENSITIVITY, HEADACHE, MENORRHAGIA, URINARY TRACT INFECTION, CYSTITIS, ANXIETY, DEPRESSION, MASS, DRY SKIN, MIGRAINE, HYPOAESTHESIA, VAGINAL DISCHARGE, ASTIGMATISM, WEIGHT INCREASED, TOOTH FRACTURE, HYPERAESTHESIA TEETH, CYST AND UTERINE LEIOMYOMA OUTCOME WAS UNKNOWN, THE DYSPAREUNIA, ALOPECIA AND BACK PAIN WAS RESOLVING AND THE VAGINAL HAEMORRHAGE, DYSMENORRHOEA AND ABDOMINAL PAIN LOWER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, ASTIGMATISM, BACK PAIN, CYST, CYSTITIS, DEPRESSION, DRY SKIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HYPERAESTHESIA TEETH, HYPERSENSITIVITY, HYPOAESTHESIA, INSOMNIA, MASS, MENORRHAGIA, MIGRAINE, NEPHROLITHIASIS, PELVIC PAIN, TOOTH FRACTURE, URINARY TRACT INFECTION, UTERINE LEIOMYOMA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 179 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 28.9 KG/SQM. HYSTEROSALPINGOGRAM - IN 2015: TOTAL BILATERAL OCCLUSION. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WERE DESCRIBED IN PATIENTS MEDICAL RECORD: FIBROIDS , DYSMENORRHEA, ANXIETY, DEPRESSION, PELVIC PAIN, CYST. QUALITY-SAFETY EVALUATION OF PTC: FINAL ASSESSMENT: SINCE NO PRODUCT WAS RETURNED TO US FOR INVESTIGATION, WE WERE UNABLE TO PERFORM AN INVESTIGATION OF THE ACTUAL DEVICE INVOLVED IN THIS COMPLAINT. TYPICALLY, WE WOULD INSPECT THE MICRO-INSERT TO LOOK FOR ANY MANUFACTURING DEFICIENCIES. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. MEDICAL ASSESSMENT: THIS PTC WAS INITIATED DUE TO A REQUEST FOR CONFIRMATION OF QUALITY. THE REPORTED ADVERSE EVENTS CONSIDERED RELATED ARE KNOWN POSSIBLE UNDESIRABLE EVENTS AND NOT INDICATIVE OF A QUALITY DEFICIT PER SE. NO BATCH NUMBER WAS REPORTED. WITHOUT THIS INFORMATION NO BATCH SIGNAL CLUSTER REVIEW IN THE GPV DATABASE FOR A MORE DETAILED STATISTICAL MEDICAL EVALUATION IS POSSIBLE. NEITHER BATCH NUMBER NOR COMPLAINT SAMPLE WERE AVAILABLE FOR FURTHER TECHNICAL INVESTIGATION. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. IN SUMMARY, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT BASED ON THIS REPORT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PFS&MR RECEIVED REPORTER INFORMATION. LOT NO ADDED. NEW EVENT WAS ADDED VAGINAL HEMORRHAGE, MENORRHAGIA , MIGRAINES, ANXIETY, DEPRESSION, URINARY TRACT INFECTION, MASS, DRY SKIN, NUMBNESS OF EXTREMITIES, DYSMENORRHEA (CRAMPING), VAGINAL DISCHARGE, ASTIGMATISM, WEIGHT GAIN, HAIR LOSS, TOOTH FRACTURE, SENSITIVITY OF TEETH, BACK PAIN, LOWER ABDOMINAL PAIN, CYST, FIBROIDS. SEVERITY ADDED BACK PAIN, LOWER ABDOMINAL PAIN. OUTCOME ADDED BACK PAIN, LOWER ABDOMINAL PAIN, HAIR LOSS, VAGINAL BLEEDING, CRAMPING, PAINFUL INTERCOURSE. CONCOMITANT DRUG AND TREATMENT DRUGS WERE ADDED. MEDICAL HISTORY AND LAB TEST WAS 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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: (B)(4)) ON 10-AUG-2015. THE MOST RECENT INFORMATION WAS RECEIVED ON 21-JUN-2019. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN/ PELVIC PAIN'), NEPHROLITHIASIS ('KIDNEY STONES') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING') 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. THE PATIENT'S MEDICAL HISTORY INCLUDED OVERWEIGHT, HYPERPLASIA, ASTHMA AND NAUSEA. CONCURRENT CONDITIONS INCLUDED KIDNEY STONES, UTERINE FIBROID, ENDOMETRIAL HYPERPLASIA, DYSFUNCTIONAL UTERINE BLEEDING, PERINEAL PAIN, NABOTHIAN CYST, UTERINE LEIOMYOMA, FLATUS AND BIOPSY OF BREAST. 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) AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2011, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("INTERCOURSE/ DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE"), URINARY TRACT INFECTION ("INFECTION: BLADDER AND UTIS") AND CYSTITIS ("BLADDER INFECTION"). IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, );") AND MENORRHAGIA ("MENORRHAGIA"). IN 2013, THE PATIENT EXPERIENCED HYPOAESTHESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS: NUMBNESS IN ARMS") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2015, THE PATIENT EXPERIENCED ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: ANXIETY") AND DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: DEPRESSION"). IN (B)(6) 2015, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN 2017, THE PATIENT EXPERIENCED ASTIGMATISM ("VISION/EYE PROBLEMS ASTIGMATISM"), TOOTH FRACTURE ("DENTAL PROBLEMS, CRACKING TEETH") AND HYPERAESTHESIA TEETH ("DENTLA PROBLEMS SENSITIVITY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED NEPHROLITHIASIS (SERIOUSNESS CRITERION HOSPITALIZATION), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FATIGUE ("FATIGUE"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), INSOMNIA ("INSOMNIA"), ABDOMINAL DISTENSION ("BLOATING"), HYPERSENSITIVITY ("ALLERGIC REACTIONS"), HEADACHE ("HEADACHES"), SKIN MASS ("RASHES OR SKIN CONDITIONS: BUMPS"), DRY SKIN ("DRY SKIN"), MIGRAINE ("MIGRAINES"), BACK PAIN ("BACK"), ABDOMINAL PAIN LOWER ("LOWER ABDOMEN") AND CYST ("HEAVY PERIOD AND CYST") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("FIBROIDS"). THE PATIENT WAS TREATED WITH ANTIBIOTICS, IBUPROFEN AND SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, NEPHROLITHIASIS, GENITAL HAEMORRHAGE, FATIGUE, ABDOMINAL PAIN, INSOMNIA, ABDOMINAL DISTENSION, HYPERSENSITIVITY, HEADACHE, MENORRHAGIA, URINARY TRACT INFECTION, CYSTITIS, ANXIETY, DEPRESSION, SKIN MASS, DRY SKIN, MIGRAINE, HYPOAESTHESIA, VAGINAL DISCHARGE, ASTIGMATISM, WEIGHT INCREASED, TOOTH FRACTURE, HYPERAESTHESIA TEETH, CYST AND UTERINE LEIOMYOMA OUTCOME WAS UNKNOWN, THE DYSPAREUNIA, ALOPECIA AND BACK PAIN WAS RESOLVING AND THE VAGINAL HAEMORRHAGE, DYSMENORRHOEA AND ABDOMINAL PAIN LOWER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, ASTIGMATISM, BACK PAIN, CYST, CYSTITIS, DEPRESSION, DRY SKIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HYPERAESTHESIA TEETH, HYPERSENSITIVITY, HYPOAESTHESIA, INSOMNIA, MENORRHAGIA, MIGRAINE, NEPHROLITHIASIS, PELVIC PAIN, SKIN MASS, TOOTH FRACTURE, URINARY TRACT INFECTION, UTERINE LEIOMYOMA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 179 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 28.9 KG/SQM. HYSTEROSALPINGOGRAM - IN 2015: TOTAL BILATERAL OCCLUSION. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WERE DESCRIBED IN PATIENTS MEDICAL RECORD: FIBROIDS , DYSMENORRHEA, ANXIETY, DEPRESSION, PELVIC PAIN, CYST. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-JUN-2019: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY FOOD AND DRUG ADMINISTRATION (REFERENCE NUMBER: MW5043446) ON 10-AUG-2015. THE MOST RECENT INFORMATION WAS RECEIVED ON 01-NOV-2017. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), NEPHROLITHIASIS ("KIDNEY STONES") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. 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), NEPHROLITHIASIS (SERIOUSNESS CRITERION HOSPITALIZATION), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FATIGUE ("FATIGUE"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), INSOMNIA ("INSOMNIA"), ABDOMINAL DISTENSION ("BLOATING"), HYPERSENSITIVITY ("ALLERGIC REACTIONS"), HEADACHE ("HEADACHES") AND DYSPAREUNIA ("INTERCOURSE"). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD SURGERY TO REMOVE THE ESSURE). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, NEPHROLITHIASIS, GENITAL HAEMORRHAGE, FATIGUE, ABDOMINAL PAIN, INSOMNIA, ABDOMINAL DISTENSION, HYPERSENSITIVITY, HEADACHE AND DYSPAREUNIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HYPERSENSITIVITY, INSOMNIA, NEPHROLITHIASIS AND PELVIC PAIN TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: FINAL ASSESSMENT: SINCE NO PRODUCT WAS RETURNED TO US FOR INVESTIGATION, WE WERE UNABLE TO PERFORM AN INVESTIGATION OF THE ACTUAL DEVICE INVOLVED IN THIS COMPLAINT. TYPICALLY, WE WOULD INSPECT THE MICRO-INSERT TO LOOK FOR ANY MANUFACTURING DEFICIENCIES. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. MEDICAL ASSESSMENT: THIS PTC WAS INITIATED DUE TO A REQUEST FOR CONFIRMATION OF QUALITY. THE REPORTED ADVERSE EVENTS CONSIDERED RELATED ARE KNOWN POSSIBLE UNDESIRABLE EVENTS AND NOT INDICATIVE OF A QUALITY DEFICIT PER SE. NO BATCH NUMBER WAS REPORTED. WITHOUT THIS INFORMATION NO BATCH SIGNAL CLUSTER REVIEW IN THE GPV DATABASE FOR A MORE DETAILED STATISTICAL MEDICAL EVALUATION IS POSSIBLE. NEITHER BATCH NUMBER NOR COMPLAINT SAMPLE WERE AVAILABLE FOR FURTHER TECHNICAL INVESTIGATION. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. IN SUMMARY, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT BASED ON THIS REPORT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-NOV-2017: SUMMONS RECEIVED - CASE UPGRADED AS INCIDENT. NEW EVENT, PAIN, ALLERGIC REACTIONS, ABNORMAL BLEEDING, HEADACHES AND INTERCOURSE WERE ADDED. SURGICAL TREATMENT WAS ADDED FOR THE EVENT PELVIC PAIN. NEW LEGAL REPORTER LAWYER WERE ADDED. ¿ESSURE LEGAL MANUFACTURE HAS CHANGED FROM BAYER HEALTHCARE, (B)(4) TO BAYER PHARMA (B)(4), AND THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP TO A PREVIOUS REPORT SUBMITTED UNDER THE FORMER LEGAL MANUFACTURER. REPORT TYPE ¿INITIAL¿ INDICATES HERE INITIAL SUBMISSION BY THE NEW LEGAL MANUFACTURER ONLY'. INCIDENT. NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 835301 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 841528 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Hospitalization| O| R |