BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIODESIGN ADDITAE

    MDR report key: 20320577 · Received September 27, 2024

    Report

    Report Number
    20320577
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    May 16, 2024
    Report Date
    May 16, 2024
    Manufacturer
    COOK BIOTECH, INC.
    Product Code
    FTM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THIS PRODUCT WAS NEEDED TO DILATE THE SMALL BOWEL AND THE BALLOON WOULD NOT INFLATE AND WE COULD SEE THE WATER COMING OUT. THE DEVICE WAS DEFECTIVE AND HAD A HOLE IN IT. HAD TO SWITCH OUT BALLOON TO A DIFFERENT BRAND AFTER THIS WAS THE 2ND ONE NOT TO WORK ON THE SAME PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1739488 BIODESIGN ADDITAE MESH, SURGICAL FTM COOK BIOTECH, INC. G51579 W4800679

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown