BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 1642637 · Received March 23, 2010

    Report

    Report Number
    MW5015287
    Event Type
    Malfunction
    Date Received
    March 23, 2010
    Date of Event
    March 19, 2010
    Report Date
    March 22, 2010
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ENDO VIVE 24 FR STANDARD BALLOON REPLACEMENT FEEDING DEVICE UPN: (B) (4). GASTROSTOMY TUBE BALLOON WOULD NOT INFLATE. NO PT INJURY. ANOTHER PRODUCT OPENED AND PROCEDURE PROCEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC BALLOON REPLACEMENT FEEDING DEVICE KNT BOSTON SCIENTIFIC 0633283

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other