BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLAR CARE GLACIER WITH WRAPON ANKLE PAD

    MDR report key: 2864019 · Received December 10, 2012

    Report

    Report Number
    2028253-2012-00027
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 6, 2012
    Report Date
    December 7, 2012
    Manufacturer
    BREG, INC.
    Product Code
    ILO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BREG CUSTOMER SERVICE REPRESENTATIVE TOOK THE REPORT FROM THE SALES REPRESENTATIVE (WHO OBTAINED THE REPORT FROM THE CUSTOMER) REGARDING THE ISSUE AND SENT OUT A NEW DEVICE TO THE CUSTOMER. THE ORIGINAL DEVICE WAS RETURNED TO BREG, INC. AND A QUALITY TECHNICIAN PERFORMED A FAILURE ANALYSIS AND FOUND THAT THE PUMP WAS IN GOOD WORKING ORDER. NO LEAKAGE WAS FOUND AFTER 24 HOURS OF SIMULATED USE. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. IT WAS NOT POSSIBLE TO REPRODUCE THE LEAKING OF THE PAD. NO MALFUNCTION OF THE DEVICE WAS DETECTED.

    Description of Event or Problem · 1

    BREG, INC RECEIVED A REPORT FROM A PATIENT THAT A POLAR CARE GLACIER COLD THERAPY SYSTEM WITH WRAP ON ANKLE PAD WAS LEAKING FROM THE PAD AND THE PATIENT'S DRESSING GOT WET. THE REPORTER ALSO INDICATED THAT THE PUMP WAS NOT WORKING. NO ADDITIONAL INFORMATION WAS GIVEN (I.E. NO PATIENT INFORMATION (APART FROM NAME), NO MEDICAL ATTENTION AS A RESULT OF LEAK). THERE WAS NO REPORT OF AN ADVERSE EVENT REQUIRING ANY MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLAR CARE GLACIER WITH WRAPON ANKLE PAD COLD THERAPY, PRODUCT CODE: ILO ILO BREG, INC. 10913 221270484

    Patients

    Seq Age Sex Outcome Treatment
    1