BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYP0 PAD

    MDR report key: 3820943 · Received May 20, 2014

    Report

    Report Number
    0001831750-2014-02996
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    March 19, 2014
    Report Date
    April 23, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED AND NO DEFECT WAS FOUND AFTER TESTING THE UNIT FOR FUNCTIONALITY. NO WATER WAS FOUND TO BE LEAKING OUT OF THE MARKED AREA OR ANY OTHER AREA OF THE BLANKET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HYPO PAD LEAKED. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HYPO PAD LEAKED. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299544 HYP0 PAD SYSTEM, THERMAL REGULATING DWJ STRYKER MEDICAL-KALAMAZOO C3 CF 20

    Patients

    Seq Age Sex Outcome Treatment
    1