BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTANT ICE COMPRESS

    MDR report key: 5348118 · Received December 31, 2015

    Report

    Report Number
    MW5058945
    Event Type
    Injury
    Date Received
    December 31, 2015
    Date of Event
    August 4, 2015
    Report Date
    October 31, 2015
    Manufacturer
    DYAD MEDICAL SOURCING, LLC
    Product Code
    KYR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    WHEN NURSE ACTIVATED AN INSTANT ICE COMPRESS, IT BUSTED IN HER FACE. SMALL TEAR TO BACK BOTTOM RIGHT CORNER NOTED AFTERWARDS. EVALUATED IN ED-DX CHEMICAL CONJUNCTIVITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861905 INSTANT ICE COMPRESS ICE PACK KYR DYAD MEDICAL SOURCING, LLC UN 150803

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other