BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPHOLD

    MDR report key: 4252972 · Received October 28, 2014

    Report

    Report Number
    4252972
    Event Type
    Malfunction
    Date Received
    October 28, 2014
    Date of Event
    October 23, 2014
    Report Date
    October 24, 2014
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC UPHOLD LITE W/ CAPIO SLIM VAGINAL SUPPORT SYSTEM WAS USED. THE BULLET DID NOT CAPTURE DURING USE REQUIRING AN ADDITIONAL CAPIO DEVICE TO BE OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688039 UPHOLD SURGICAL MESH OTP BOSTON SCIENTIFIC CORPORATION M0068318170 ML00002471

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR UNKNOWN.