BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5580508 · Received April 15, 2016

    Report

    Report Number
    2951250-2016-00330
    Event Type
    Injury
    Date Received
    April 15, 2016
    Report Date
    January 23, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP RECEIVED ON 23-MAY-2016: QUALITY SAFETY EVALUATION OF PTC: PTC GLOBAL NUMBER: (B)(4). IN THIS CASE NO PRODUCT WAS RETURNED. FOR CASES WHERE A DEVICE FAILURE DURING INSERTION IS REPORTED, WE CONDUCT AN INVESTIGATION OF ANY RETURNED DEVICE. 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. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. THE PTC INVESTIGATION WAS INITIATED AND THE OUTCOME OF THE INVESTIGATION RESULTED IN AN UNCONFIRMED QUALITY DEFECT. FOLLOW-UP RECEIVED ON 24-MAY-2016: THE REQUIRED NUMBER OF FOLLOW-UP ATTEMPTS HAVE BEEN COMPLETED, WITH NO RESPONSE TO DATE. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS MEDICALLY CONFIRMED CASE REPORT REFERS TO A FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND HAD ABDOMINAL PAIN. ESSURE WAS REMOVED APPROXIMATELY 3 AND A HALF YEARS AFTER ITS INSERTION. THIS EVENT WAS CONSIDERED SERIOUS DUE TO MEDICAL SIGNIFICANCE AND IS LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. AFTER ESSURE INSERTION, ABDOMINAL PAIN MAY OCCUR. GIVEN THE NATURE OF THE REPORTED EVENT, AND IN THE LACK OF AN ALTERNATIVE EXPLANATION, CAUSALITY WITH ESSURE CANNOT BE EXCLUDED. NON-SERIOUS EVENTS WERE ALSO REPORTED. THIS CASE WAS REGARDED AS INCIDENT SINCE DEVICE REMOVAL WAS REQUIRED. THE OUTCOME OF THE TECHNICAL INVESTIGATION RESULTED IN AN UNCONFIRMED QUALITY DEFECT. NO FURTHER INFORMATION IS EXPECTED.

    Additional Manufacturer Narrative · 1

    DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A PHYSICIAN IN UNITED STATES ON 22-FEB-2016 WHICH REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED ON (B)(6) 2012, LOT NUMBER 922610, FOR PERMANENT CONTRACEPTION. PATIENT PRESENTED WITH ABDOMINAL PAIN, WEIGHT GAIN AND METAL TASTE IN MOUTH. ESSURE WAS REMOVED SOMETIME IN (B)(6) 2015. PATIENT WAS DOING BETTER. COMPANY CAUSALITY COMMENT:THIS SPONTANEOUS MEDICALLY CONFIRMED CASE REPORT REFERS TO A FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND HAD ABDOMINAL PAIN. ESSURE WAS REMOVED APPROXIMATELY 3 AND A HALF YEARS AFTER ITS INSERTION. THIS EVENT WAS CONSIDERED SERIOUS DUE TO MEDICAL SIGNIFICANCE AND IS LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. AFTER ESSURE INSERTION, ABDOMINAL PAIN MAY OCCUR. GIVEN THE NATURE OF THE REPORTED EVENT, AND IN THE LACK OF AN ALTERNATIVE EXPLANATION, CAUSALITY WITH ESSURE CANNOT BE EXCLUDED. NON-SERIOUS EVENTS WERE ALSO REPORTED. THIS CASE WAS REGARDED AS INCIDENT SINCE DEVICE REMOVAL WAS REQUIRED. A PRODUCT TECHNICAL ANALYSIS AND FURTHER INFORMATION ARE EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237026 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 922610

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other| R