BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6796978 · Received August 16, 2017

    Report

    Report Number
    2951250-2017-02944
    Event Type
    Injury
    Date Received
    August 16, 2017
    Date of Event
    November 15, 2011
    Report Date
    July 27, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (US FOOD AND DRUG ADMINISTRATION-FDA, REFERENCE NUMBER: MW5060680) ON (B)(6) 2016. THE MOST RECENT INFORMATION WAS RECEIVED ON (B)(6) 2018. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF VAGINAL CANCER ("VAGINAL CANCER") AND ABDOMINAL PAIN ("DEBILATING ABDOMINAL PAIN") IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880435) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED OVERWEIGHT. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED THE FIRST EPISODE OF HOT FLUSH ("HOT FLASHES /HOT FLASHES"), PREMATURE MENOPAUSE ("EARLY ONSET OF MENOPAUSE /EARLY ONSET OF MENOPAUSE"), ALOPECIA ("HAIR LOSS / HAIR LOSS"), DYSPAREUNIA ("PAIN DURING INTERCOURSE / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), WEIGHT INCREASED ("WEIGHT GAIN /WEIGHT GAIN"), FATIGUE ("FATIGUE /FATIGUE") AND WEIGHT DECREASED ("WEIGHT LOSS"). ON (B)(6) 2011, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA DISABILITY AND MEDICALLY SIGNIFICANT). ON (B)(6) 2012, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("MENSTRUAL CHANGES"). ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("SEVERE PELVIC PAIN /PAIN") AND HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). IN JANUARY 2016, THE PATIENT EXPERIENCED VAGINAL CANCER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ARTHRALGIA ("JOINT PAIN"), HEADACHE ("HEADACHES"), ABDOMINAL PAIN LOWER ("SEVERE, LOWER ABDOMINAL PAIN / SEVERE ABDOMINAL CRAMPING"), MENSTRUATION IRREGULAR ("IRREGULAR MENSES"), UTERINE PAIN ("UTERINE PAIN"), DEPRESSION ("DEPRESSION"), THE SECOND EPISODE OF HOT FLUSH ("HOT FLASHES"), DRY SKIN ("SKIN ISSUES (ITCHING AND DRY PATCHES THAT RESEMBLE BURN MARKS) / DRY PATCHES AND ITCHING") WITH DRY SKIN, NAUSEA ("NAUSEA"), DYSMENORRHOEA ("ABNORMALLY SEVERE MENSTRUAL PAIN") AND RASH ("RASH"). THE PATIENT WAS TREATED WITH SURGERY ((B)(6) 2017, PLAINTIFF UNDERWENT A TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY.). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE VAGINAL CANCER, ABDOMINAL PAIN LOWER, PELVIC PAIN, MENSTRUATION IRREGULAR, UTERINE PAIN, DEPRESSION, THE LAST EPISODE OF HOT FLUSH, ALOPECIA, DRY SKIN, NAUSEA, DYSPAREUNIA, FATIGUE AND DYSMENORRHOEA WAS RESOLVING, THE ABDOMINAL PAIN AND ARTHRALGIA HAD NOT RESOLVED AND THE PREMATURE MENOPAUSE, HEADACHE, HORMONE LEVEL ABNORMAL, MENSTRUAL DISORDER, WEIGHT DECREASED AND RASH OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALOPECIA, ARTHRALGIA, DEPRESSION, DRY SKIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, HORMONE LEVEL ABNORMAL, MENSTRUAL DISORDER, MENSTRUATION IRREGULAR, NAUSEA, PELVIC PAIN, PREMATURE MENOPAUSE, RASH, UTERINE PAIN, VAGINAL CANCER, WEIGHT DECREASED, WEIGHT INCREASED, THE FIRST EPISODE OF HOT FLUSH AND THE SECOND EPISODE OF HOT FLUSH TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2017, PLAINTIFF UNDERWENT A TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY AND PARTIAL VAGINECTOMY, DURING WHICH HER CERVIX, UTERUS, BOTH FALLOPIAN TUBES BOTH OVARIES, AND PART OF HER VAGINA WERE ALL REMOVED. SYMPTOMS MOSTLY RESOLVED THROUGH SOME REMAIN. CURRENT WEIGHT 168 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 27.8 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: CONFIRMING FULL OCCLUSION OF FALLOPIAN TUBES QUALITY-SAFETY EVALUATION OF PTC: IN THIS CASE NO PRODUCT WAS RETURNED. WE CONDUCTED A REVIEW OF THE MANUFACTURING BATCH RECORD AND CONFIRMED THAT FINAL PRODUCT TESTING FOR THIS LOT WAS PERFORMED PER REQUIREMENTS AND THE PRODUCT MET ALL RELEASE REQUIREMENTS. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, IT IS POSSIBLE THE ESSURE DEVICE COULD HAVE BEEN DEFECTIVE PRIOR TO REMOVAL FROM THE PACKAGE. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. THE REPORTED MEDICAL EVENTS ARE NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. THE REVIEW OF THE MANUFACTURING AND RELEASE DOCUMENTATION DID NOT REVEAL ANY RELEVANT DEFICIENCIES OR ANY REASON TO SUSPECT A QUALITY DEFECT. NO COMPLAINT SAMPLE WAS PROVIDED FOR FURTHER INVESTIGATION THEREFORE THE COMPLAINT COULD NOT BE EVALUATED IN GREATER DETAIL. NO SIMILAR AE CASE REPORTS WERE IDENTIFIED FOR THE REPORTED BATCH. THE TECHNICAL ASSESSMENT CONCLUDED A QUALITY DEFECT WAS NOT CONFIRMED BUT CONSIDERED PLAUSIBLE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: EVENTS - "HORMONAL CHANGES, MENSTRUAL CHANGES, WEIGHT LOSS, RASH ", REPORTER, CONCOMITANT CONDITION ADDED FROM PFS. INCIDENT AT THE TIME OF REPORTING, 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.

    Additional Manufacturer Narrative · 0

    E WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (US FOOD AND DRUG ADMINISTRATION-FDA, REFERENCE NUMBER: MW (B)(4)) ON 11-APR-2016. THE MOST RECENT INFORMATION WAS RECEIVED ON 10-JUL-2018. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("DEBILATING ABDOMINAL PAIN") AND VAGINAL CANCER ("VAGINAL CANCER") IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880435) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED OVERWEIGHT. CONCOMITANT PRODUCTS INCLUDED METOPROLOL TARTRATE (LOPRESSOR). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED THE FIRST EPISODE OF HOT FLUSH ("HOT FLASHES /HOT FLASHES"), PREMATURE MENOPAUSE ("EARLY ONSET OF MENOPAUSE /EARLY ONSET OF MENOPAUSE"), ALOPECIA ("HAIR LOSS / HAIR LOSS"), DYSPAREUNIA ("PAIN DURING INTERCOURSE / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), WEIGHT INCREASED ("WEIGHT GAIN /WEIGHT GAIN"), FATIGUE ("FATIGUE /FATIGUE") AND WEIGHT DECREASED ("WEIGHT LOSS"). ON (B)(6) 2011, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA DISABILITY AND MEDICALLY SIGNIFICANT). ON (B)(6) 2012, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("MENSTRUAL CHANGES"). ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("SEVERE PELVIC PAIN /PAIN") AND HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). IN (B)(6) 2016, THE PATIENT EXPERIENCED VAGINAL CANCER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ARTHRALGIA ("JOINT PAIN"), HEADACHE ("HEADACHES"), ABDOMINAL PAIN LOWER ("SEVERE, LOWER ABDOMINAL PAIN / SEVERE ABDOMINAL CRAMPING"), MENSTRUATION IRREGULAR ("IRREGULAR MENSES"), UTERINE PAIN ("UTERINE PAIN"), DEPRESSION ("DEPRESSION"), THE SECOND EPISODE OF HOT FLUSH ("HOT FLASHES"), DRY SKIN ("SKIN ISSUES (ITCHING AND DRY PATCHES THAT RESEMBLE BURN MARKS) / DRY PATCHES AND ITCHING") WITH DRY SKIN, NAUSEA ("NAUSEA"), DYSMENORRHOEA ("ABNORMALLY SEVERE MENSTRUAL PAIN") AND RASH ("RASH"). THE PATIENT WAS TREATED WITH SURGERY ((B)(6) 2017, PLAINTIFF UNDERWENT A TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN AND DYSMENORRHOEA HAD RESOLVED, THE VAGINAL CANCER, ABDOMINAL PAIN LOWER, PELVIC PAIN, MENSTRUATION IRREGULAR, UTERINE PAIN, DEPRESSION, THE LAST EPISODE OF HOT FLUSH, ALOPECIA, DRY SKIN, NAUSEA, DYSPAREUNIA AND FATIGUE WAS RESOLVING, THE PREMATURE MENOPAUSE, HEADACHE, HORMONE LEVEL ABNORMAL, MENSTRUAL DISORDER, WEIGHT DECREASED AND RASH OUTCOME WAS UNKNOWN AND THE ARTHRALGIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALOPECIA, ARTHRALGIA, DEPRESSION, DRY SKIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, HORMONE LEVEL ABNORMAL, MENSTRUAL DISORDER, MENSTRUATION IRREGULAR, NAUSEA, PELVIC PAIN, PREMATURE MENOPAUSE, RASH, UTERINE PAIN, VAGINAL CANCER, WEIGHT DECREASED, WEIGHT INCREASED, THE FIRST EPISODE OF HOT FLUSH AND THE SECOND EPISODE OF HOT FLUSH TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2017, PLAINTIFF UNDERWENT A TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY AND PARTIAL VAGINECTOMY, DURING WHICH HER CERVIX, UTERUS, BOTH FALLOPIAN TUBES BOTH OVARIES, AND PART OF HER VAGINA WERE ALL REMOVED. SYMPTOMS MOSTLY RESOLVED THROUGH SOME REMAIN. CURRENT WEIGHT 168 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 27.8 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: CONFIRMING FULL OCCLUSION OF FALLOPIAN TUBES. QUALITY-SAFETY EVALUATION OF PTC: IN THIS CASE NO PRODUCT WAS RETURNED. WE CONDUCTED A REVIEW OF THE MANUFACTURING BATCH RECORD AND CONFIRMED THAT FINAL PRODUCT TESTING FOR THIS LOT WAS PERFORMED PER REQUIREMENTS AND THE PRODUCT MET ALL RELEASE REQUIREMENTS. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, IT IS POSSIBLE THE ESSURE DEVICE COULD HAVE BEEN DEFECTIVE PRIOR TO REMOVAL FROM THE PACKAGE. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. THE REPORTED MEDICAL EVENTS ARE NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. THE REVIEW OF THE MANUFACTURING AND RELEASE DOCUMENTATION DID NOT REVEAL ANY RELEVANT DEFICIENCIES OR ANY REASON TO SUSPECT A QUALITY DEFECT. NO COMPLAINT SAMPLE WAS PROVIDED FOR FURTHER INVESTIGATION THEREFORE THE COMPLAINT COULD NOT BE EVALUATED IN GREATER DETAIL. NO SIMILAR AE CASE REPORTS WERE IDENTIFIED FOR THE REPORTED BATCH. THE TECHNICAL ASSESSMENT CONCLUDED A QUALITY DEFECT WAS NOT CONFIRMED BUT CONSIDERED PLAUSIBLE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-JUL-2018: PFS RECEIVED- OUTCOME OF ABDOMINAL PAIN, DYSMENORRHOEA CHANGED TO RECOVERED / RESOLVED. CONCOMITANT MEDICATION WERE ADDED. INCIDENT: AT THE TIME OF REPORTING, 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.

    Description of Event or Problem · 1

    THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY US FOOD AND DRUG ADMINISTRATION-FDA (REFERENCE NUMBER: MW5060680) ON 11-APR-2016. THE MOST RECENT INFORMATION WAS RECEIVED ON 01-AUG-2017. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF VAGINAL CANCER ("VAGINAL CANCER") AND ABDOMINAL PAIN ("DEBILATING ABDOMINAL PAIN") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880435) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, 6 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA DISABILITY AND MEDICALLY SIGNIFICANT). IN (B)(6) 2016, THE PATIENT EXPERIENCED VAGINAL CANCER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED THE FIRST EPISODE OF HOT FLUSH ("HOT FLASHES"), PREMATURE MENOPAUSE ("EARLY ONSET OF MENOPAUSE"), ARTHRALGIA ("JOINT PAIN"), HEADACHE ("HEADACHES"), ABDOMINAL PAIN LOWER ("SEVERE, LOWER ABDOMINAL PAIN / SEVERE ABDOMINAL CRAMPING"), PELVIC PAIN ("SEVERE PELVIC PAIN"), MENSTRUATION IRREGULAR ("IRREGULAR MENSES"), UTERINE PAIN ("UTERINE PAIN"), DEPRESSION ("DEPRESSION"), THE SECOND EPISODE OF HOT FLUSH ("HOT FLASHES"), ALOPECIA ("HAIR LOSS"), PRURITUS ("SKIN ISSUES (ITCHING AND DRY PATCHES THAT RESEMBLE BURN MARKS)") WITH DRY SKIN, NAUSEA ("NAUSEA"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), WEIGHT INCREASED ("WEIGHT GAIN"), FATIGUE ("FATIGUE") AND DYSMENORRHOEA ("ABNORMALLY SEVERE MENSTRUAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY ((B)(6) 2017, PLAINTIFF UNDERWENT A TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY.). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE VAGINAL CANCER, ABDOMINAL PAIN LOWER, PELVIC PAIN, MENSTRUATION IRREGULAR, UTERINE PAIN, DEPRESSION, THE LAST EPISODE OF HOT FLUSH, ALOPECIA, PRURITUS, NAUSEA, DYSPAREUNIA, FATIGUE AND DYSMENORRHOEA WAS RESOLVING, THE ABDOMINAL PAIN AND ARTHRALGIA HAD NOT RESOLVED AND THE PREMATURE MENOPAUSE AND HEADACHE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALOPECIA, ARTHRALGIA, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, MENSTRUATION IRREGULAR, NAUSEA, PELVIC PAIN, PREMATURE MENOPAUSE, PRURITUS, UTERINE PAIN, VAGINAL CANCER, WEIGHT INCREASED, THE FIRST EPISODE OF HOT FLUSH AND THE SECOND EPISODE OF HOT FLUSH TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2017, PLAINTIFF UNDERWENT A TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY AND PARTIAL VAGINECTOMY, DURING WHICH HER CERVIX, UTERUS, BOTH FALLOPIAN TUBES BOTH OVARIES, AND PART OF HER VAGINA WERE ALL REMOVED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2012: CONFIRMING FULL OCCLUSION OF FALLOPIAN TUBES. QUALITY-SAFETY EVALUATION OF PTC: IN THIS CASE NO PRODUCT WAS RETURNED. WE CONDUCTED A REVIEW OF THE MANUFACTURING BATCH RECORD AND CONFIRMED THAT FINAL PRODUCT TESTING FOR THIS LOT WAS PERFORMED PER REQUIREMENTS AND THE PRODUCT MET ALL RELEASE REQUIREMENTS. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, IT IS POSSIBLE THE ESSURE DEVICE COULD HAVE BEEN DEFECTIVE PRIOR TO REMOVAL FROM THE PACKAGE. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. THE REPORTED MEDICAL EVENTS ARE NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. THE REVIEW OF THE MANUFACTURING AND RELEASE DOCUMENTATION DID NOT REVEAL ANY RELEVANT DEFICIENCIES OR ANY REASON TO SUSPECT A QUALITY DEFECT. NO COMPLAINT SAMPLE WAS PROVIDED FOR FURTHER INVESTIGATION THEREFORE THE COMPLAINT COULD NOT BE EVALUATED IN GREATER DETAIL. NO SIMILAR AE CASE REPORTS WERE IDENTIFIED FOR THE REPORTED BATCH. THE TECHNICAL ASSESSMENT CONCLUDED A QUALITY DEFECT WAS NOT CONFIRMED BUT CONSIDERED PLAUSIBLE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-AUG-2017: CASE CLASSIFICATION WAS UPDATED TO POTENTIALLY LEGAL AND NEW REPORTERS WAS ADDED. ALSO NEW EVENTS,START DATE AND STOP DATE WAS ADDED AND LAB DATA ADDED. INCIDENT. AT THE TIME OF REPORTING, 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
    577147 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 880435

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other| R| S LOPRESSOR