BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESSURE

    MDR report key: 3896784 · Received June 6, 2014

    Report

    Report Number
    2951250-2014-00201
    Event Type
    Other
    Date Received
    June 6, 2014
    Report Date
    January 19, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP RECEIVED ON (B)(4) 2014: PRODUCT TECHNICAL COMPLAINT INVESTIGATION AND FINAL ASSESSMENT WERE RECEIVED: THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT (PTC) - NEAR INCIDENT REPORT. THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS: (B)(4) AND THE LOCAL NUMBER IS (B)(4). 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, THE OUTER CATHETER, THE INNER CATHETER, AND ALL PARTS WITHIN THE HANDLE ASSEMBLY TO CONFIRM THAT ALL ARE WITHIN MANUFACTURING SPECIFICATIONS. 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 AT THIS TIME. NO CAPA INVESTIGATION IS REQUIRED AT THIS TIME PER CRITERIA ESTABLISHED IN (B)(4), "PROCESSING ESSURE CASES IN (B)(4)." SINCE NEITHER PRODUCT WAS RETURNED FOR INSPECTION NOR DO WE HAVE A PHOTOGRAPH OF THE ACTUAL DEVICE, WE CANNOT DETERMINE EXACTLY WHAT THE FAILURE IS. BASED ON OUR EXPERIENCE WITH DEVICE COMPLAINTS OF A SIMILAR NATURE, IT IS LIKELY THE REPORTER IS REFERRING TO AN EVENT IN WHICH THE MICRO­ INSERT WAS BENT OR STRETCHED INTO A SHAPE WHICH RENDERED THE DEVICE TO BE UNUSABLE, AND HENCE, "BROKEN." SINCE NO PRODUCT WAS RETURNED FOR INVESTIGATION, WE CANNOT CONFIRM THIS QUALITY COMPLAINT. MEDICAL ASSESSMENT: THE MEDICAL EVENT REPORTED IS NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. ADDITIONALLY, THIS CASE REPORTED BREAKAGE AND DISLOCATION WITH A PIECE OF COIL FROM THE FALLOPIAN TUBE BEING IN THE UTERUS BUT THESE EVENTS ARE ALSO NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. NO COMPLAINT SAMPLE WAS PROVIDED FOR A TECHNICAL INVESTIGATION. NO BATCH NUMBER WAS REPORTED. NEITHER A TECHNICAL BATCH INVESTIGATION NOR A BATCH CLUSTER REVIEW IN THE (B)(4) DATABASE FOR A MORE DETAILED STATISTICAL MEDICAL EVALUATION IS POSSIBLE WITHOUT A BATCH NUMBER. AT THE TIME OF THIS MEDICAL ASSESSMENT THE TECHNICAL INVESTIGATION CONCLUDED "UNCONFIRMED QUALITY DEFECT". BASED ON THE INFORMATION AVAILABLE, THERE IS NO REASON TO SUSPECT A QUALITY DEFECT. F/U ON (B)(4) 2014: NO RESPONSE TO DATE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A FEMALE CONSUMER OF UNSPECIFIED AGE VIA REGULATORY AUTHORITY (CASE# (B)(4)) IN UNITED STATES ON (B)(4) 2014 WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) IMPLANTED AND EXPERIENCED LESION IN MY BLADDER, PIECE OF COIL DISLODGED FROM FALLOPIAN TUBE AND PIECE OF COIL IS IN UTERUS. NO INFORMATION GIVEN ON CONSUMER'S HISTORY, PAST DRUGS AND CONCURRENT CONDITIONS. IT IS NOT REPORTED WHETHER THE CONSUMER RECEIVED ANY CONCOMITANT MEDICATION. IN 2008 THE CONSUMER HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) IMPLANTED. ON (B)(6) 2014, THE CONSUMER WAS DIAGNOSED WITH PIECE OF COIL DISLODGED FROM FALLOPIAN TUBE AND WAS IN HER UTERUS. ALSO A LESION WAS DISCOVERED ON HER BLADDER AND SHE WOULD NEED A SURGERY TO REMOVE THE COIL FOUND IN HER UTERUS AND THE LESION ON HER BLADDER. NO ASSESSMENT WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332518 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1