BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE SINGLE USE HOT PACK

    MDR report key: 19809881 · Received July 22, 2024

    Report

    Report Number
    MW5157487
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Date of Event
    July 17, 2024
    Report Date
    July 17, 2024
    Manufacturer
    MEDLINE INDUSTRIES, LP - NORTHFIELD
    Product Code
    IMD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    HOT PACK EXPLODED WHEN USED PER MANUFACTURE DIRECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358691 MEDLINE SINGLE USE HOT PACK PACK, HOT OR COLD, DISPOSABLE IMD MEDLINE INDUSTRIES, LP - NORTHFIELD VN24068-1718

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose