BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTANT COLD PACK

    MDR report key: 7560572 · Received June 1, 2018

    Report

    Report Number
    7560572
    Event Type
    Malfunction
    Date Received
    June 1, 2018
    Date of Event
    May 15, 2018
    Report Date
    May 25, 2018
    Manufacturer
    DYNAREX CORPORATION
    Product Code
    IMD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WHEN THE RN SQUEEZED THE INSTANT COLD PACK TO ACTIVATE, THE BAG BURST OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403098 INSTANT COLD PACK PACK, HOT OR COLD, DISPOSABLE IMD DYNAREX CORPORATION 4512 37366

    Patients

    Seq Age Sex Outcome Treatment
    1 NO OTHER THERAPIES