BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPHOLD VAGINAL VAULT SUPPORT KIT

    MDR report key: 2190752 · Received July 28, 2011

    Report

    Report Number
    MW5021575
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CAPIO DEVICE MISFIRED WHILE ATTEMPTING TO SECURE MESH. THE MISFIRE CAUSED THE BULLET TIP TO BREAK OFF AND BE RETAINED IN THE PT AND CAUSED THE MESH NOT TO BE SECURED. THERE WAS NOT ADVERSE OUTCOME OR HARM TO PT. THE SURGEON THOUGHT IT WAS MORE HARMFUL TO PT TO ATTEMPT RETRIEVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UPHOLD VAGINAL VAULT SUPPORT KIT CAPIO DEVICE SECURE MESH KIT FTL BOSTON SCIENTIFIC M0068317080 ML00000106

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR