BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WILSON COOK MEDICAL

    MDR report key: 203713 · Received December 24, 1998

    Report

    Report Number
    MW1015301
    Event Type
    Malfunction
    Date Received
    December 24, 1998
    Date of Event
    December 14, 1998
    Report Date
    December 21, 1998
    Manufacturer
    WILSON-COOK MEDICAL, INC.
    Product Code
    KNQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHEN ATTEMPTING TO INFLATE THE ESOPHAGEAL BALLOON DURING GASTROSCOPY IT WAS NOTED ON THE VIEWING MONITOR THAT THE BALLOON HAD BECOME DETACHED FROM THE CATHETER PROXIMATELY. THE BALLOON WAS SUBSEQUENTLY REMOVED FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WILSON COOK MEDICAL ESOPHAGEAL DILATING BALLOON KNQ WILSON-COOK MEDICAL, INC. QUANTUM TTC QD-18X8 1195508

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR