BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 3578837 · Received January 16, 2014

    Report

    Report Number
    3005099803-2014-00323
    Event Type
    Injury
    Date Received
    January 16, 2014
    Report Date
    December 30, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    OTP
    PMA / PMN Number
    K081048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE PATIENT'S ATTORNEY, A BOSTON SCIENTIFIC DEVICE WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED AN UNKNOWN INJURY. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE COMPLAINANT ON AUGUST 21, 2104 NOTED THE PATIENT EXPERIENCED EROSION, MESH CONTRACTION, INFECTION, FISTULA, INFLAMMATION, SCAR TISSUE, ORGAN PERFORATION, DYSPAREUNIA, BLOOD LOSS, NEUROPATHIC AND OTHER ACUTE AND CHRONIC NERVE DAMAGE AND PAIN, PUDENDAL NERVE DAMAGE, PELVIC FLOOR DAMAGE, CHRONIC PAIN, OPERATIONS TO LOCATE AND REMOVE MESH, OPERATIONS TO ATTEMPT TO REPAIR PELVIC ORGANS, TISSUE, AND NERVE DAMAGE, THE USE OF PAIN CONTROL AND OTHER MEDICATIONS, INJECTIONS INTO VARIOUS AREAS OF THE PELVIS, SPINE AND THE VAGINA, AND OPERATIONS TO REMOVE PORTIONS OF THE FEMALE GENITALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43002 UPHOLD VAGINAL SUPPORT SYSTEM MESH, SURGICAL, SYNTHETIC OTP BOSTON SCIENTIFIC - MARLBOROUGH M0068317080

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R