BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMA-KOOL

    MDR report key: 19855638 · Received July 29, 2024

    Report

    Report Number
    19855638
    Event Type
    Malfunction
    Date Received
    July 29, 2024
    Date of Event
    March 10, 2024
    Report Date
    March 28, 2024
    Manufacturer
    NORTECH LABORATORIES, INC.
    Product Code
    IME
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHEN REMOVING GEL PACK FROM SLEEVE, NOTICED THAT STAFF HANDS WERE "WET," INSPECTED THE GEL PACK, FOUND HOLE THAT WAS LEAKING THE GEL FROM INSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2466529 THERMA-KOOL PACK, HOT OR COLD, REUSABLE IME NORTECH LABORATORIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown