BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 1951371 · Received January 6, 2011

    Report

    Report Number
    3005099803-2010-05304
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 13, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NEEDLE DETACHMENT. THE COMPLAINANT INDICATED THAT THE DEVICE WILL BE RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RECEIVED. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING AN ANTERIOR PELVIC FLOOR REPAIR PROCEDURE USING AN UPHOLD VAGINAL SUPPORT SYSTEM, WHILE THE PHYSICIAN WAS THROWING THE FIRST MESH LEG ASSEMBLY THROUGH TISSUE, THE NEEDLE DETACHED FROM THE SUTURE AND FELL INTO THE PATIENT CAVITY. THE PHYSICIAN REPORTEDLY ATTEMPTED TO LOCATE THE NEEDLE WITH PALPATION AND DECIDED TO LEAVE THE NEEDLE INSIDE THE PATIENT. THE PHYSICIAN COMPLETED THE PROCEDURE WITH THIS UPHOLD VAGINAL SUPPORT SYSTEM WITH NO COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY "FINE" POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UPHOLD VAGINAL SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317080 1ML0092003

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other