BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANAGO ICE PACK

    MDR report key: 15972 · Received September 8, 1994

    Report

    Report Number
    MW1003292
    Event Type
    Malfunction
    Date Received
    September 8, 1994
    Date of Event
    August 18, 1994
    Report Date
    August 29, 1994
    Manufacturer
    TECNOL, INC.
    Product Code
    IMD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LEAKING ICE BAG; HOLE DISCOVERED AT BOTTOM SEAM. NO INJURY TO PT, PRODUCT PROBLEM ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANAGO ICE PACK ICE PACK IMD TECNOL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other