BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACK, HOT OR COLD, REUSEABLE

    MDR report key: 5852938 · Received August 8, 2016

    Report

    Report Number
    5852938
    Event Type
    Malfunction
    Date Received
    August 8, 2016
    Date of Event
    July 13, 2016
    Report Date
    July 25, 2016
    Manufacturer
    POLAR PRODUCTS INC.
    Product Code
    IME
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WETNESS NOTICED ON TOP OF KNEE BETWEEN ICE PACK AND ACE BANDAGE. MANUFACTURER RESPONSE FOR POLAR ICE PACK, (BRAND NOT PROVIDED) (PER SITE REPORTER): WILL COMMUNICATE ISSUE TO INTERNAL QUALITY; DEFECTIVE PRODUCT NOT KEPT BY HOSPITAL TO GIVE TO SUPPLIER SO SUPPLIER UNABLE TO PERFORM QUALITY CHECKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505872 PACK, HOT OR COLD, REUSEABLE IME POLAR PRODUCTS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 ACE BANDAGE PLACED ON PATIENT