BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACE INSTANT COLD COMPRESS

    MDR report key: 350426 · Received September 6, 2001

    Report

    Report Number
    2243072-2001-00007
    Event Type
    Injury
    Date Received
    September 6, 2001
    Date of Event
    May 17, 1999
    Report Date
    September 5, 2001
    Manufacturer
    BECTON DICKINSON
    Product Code
    IME
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    NOTIIFED IN 08/2001-CONSUMER CLAIMS CONSUMER RECEIVED "THERMAL BURNING" DUE TO OVEREXPOSURE OF ICE PACKS. CONSUMER WAS TAKEN TO THE EMERGENCY ROOM FOR TREATMENT. CONSUMER USED THREE DIFFERENT TYPES OF ICE PACKS-ONE WAS BD ACE BRAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40457 ACE INSTANT COLD COMPRESS COLD COMPRESS IME BECTON DICKINSON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention