BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9122058 · Received September 26, 2019

    Report

    Report Number
    2951250-2019-08549
    Event Type
    Injury
    Date Received
    September 26, 2019
    Report Date
    August 24, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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. 893038) 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 ESSURE CONFIRMATION TEST". 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), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), VAGINAL INFECTION ("VAGINAL INFECTIONS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), MIGRAINE ("MIGRAINES") AND ALOPECIA ("HAIR LOSS"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, ABDOMINAL PAIN, BACK PAIN, VAGINAL INFECTION, VAGINAL DISCHARGE, FATIGUE, MIGRAINE AND ALOPECIA OUTCOME WAS UNKNOWN AND THE MENORRHAGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BACK PAIN, DYSMENORRHOEA, FATIGUE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, VAGINAL DISCHARGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN DATE OF INSERTION (B)(6) 2012( SUMMONS) AND (B)(6) 2012 (PFS). MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-AUG-2020: MR RECEIVED NEW REPORTER INFORMATION AND LOT NO WAS 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.

    Additional Manufacturer Narrative · 0

    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. 893038) 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 ESSURE CONFIRMATION TEST". 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), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), VAGINAL INFECTION ("VAGINAL INFECTIONS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), MIGRAINE ("MIGRAINES") AND ALOPECIA ("HAIR LOSS"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, ABDOMINAL PAIN, BACK PAIN, VAGINAL INFECTION, VAGINAL DISCHARGE, FATIGUE, MIGRAINE AND ALOPECIA OUTCOME WAS UNKNOWN AND THE MENORRHAGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BACK PAIN, DYSMENORRHOEA, FATIGUE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, VAGINAL DISCHARGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN DATE OF INSERTION (B)(6) 2012 (SUMMONS) AND (B)(6) 2012 (PFS). LOT NUMBER: 893038, MANUFACTURING DATE: 2011-08, EXPIRATION DATE: 2014-08. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-AUG-2020: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS 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.

    Description of Event or Problem · 1

    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. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO ESSURE CONFIRMATION TEST". 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), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), VAGINAL INFECTION ("VAGINAL INFECTIONS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), MIGRAINE ("MIGRAINES") AND ALOPECIA ("HAIR LOSS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, ABDOMINAL PAIN, BACK PAIN, VAGINAL INFECTION, VAGINAL DISCHARGE, FATIGUE, MIGRAINE AND ALOPECIA OUTCOME WAS UNKNOWN AND THE MENORRHAGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BACK PAIN, DYSMENORRHOEA, FATIGUE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, VAGINAL DISCHARGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN DATE OF INSERTION (B)(6) 2012 (SUMMONS) AND (B)(6) 2012 (PFS). QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-SEP-2019: PFS RECEIVED: INCIDENT CATEGORY UPDATED. PREVIOUSLY REPORTED EVENT INJURY REPLACED BY NEW EVENTS DYSMENORRHEA (CRAMPING), PELVIC/ABDOMINAL PAIN, BACK PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), VAGINAL INFECTIONS, VAGINAL DISCHARGE, FATIGUE, MIGRAINES, HAIR LOSS AND DID NOT UNDERWENT ESSURE CONFIRMATION TEST. OUTCOME FOR THE EVENT MENORRHAGIA (HEAVY MENSTRUAL BLEEDING) ADDED AS RECOVERED / RESOLVED. PATIENT DOB ADDED. REPORTER INFORMATION, PRODUCT INDICATION AND REMOVAL DATE UPDATED. NO LOT NUMBER 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
    916699 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 893038 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R