BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-THERM INSTANT HOT COMPRESS

    MDR report key: 558193 · Received October 27, 2004

    Report

    Report Number
    MW1033676
    Event Type
    Malfunction
    Date Received
    October 27, 2004
    Date of Event
    October 23, 2004
    Report Date
    October 27, 2004
    Manufacturer
    MEDLINE, INC.
    Product Code
    IMD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INSTANT HOT PACK SEAM LEAKED-2ND INCIDENT-FOUND BEFORE PLACED ON RESIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-THERM INSTANT HOT COMPRESS INSTANT HOT COMPRESS IMD MEDLINE, INC. * 04218

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Other