BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTANT ICE COMPRESS

    MDR report key: 17571 · Received November 11, 1994

    Report

    Report Number
    MW1003982
    Event Type
    Injury
    Date Received
    November 11, 1994
    Date of Event
    October 30, 1994
    Report Date
    October 31, 1994
    Manufacturer
    GAM INDUSTRIES, INC.
    Product Code
    IMD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ICE PACK APPLIED TO ANKLE SPRAIN. CONTENTS BURST AND SPRAYED INTO PT'S EYE CAUSING EXCESSIVE BURNING (PH CHANGED TO 9.0) AND A DECREASE IN VISUAL ACUITY. ICE PACK CONTAINS AMMONIA NITRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSTANT ICE COMPRESS ICE PACK IMD GAM INDUSTRIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other| S