BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPERATURE THERAPY PAD

    MDR report key: 3954602 · Received July 24, 2014

    Report

    Report Number
    0001831750-2014-03169
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 20, 2014
    Report Date
    July 1, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    ILO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SCRAPPED BY THE USER FACILITY AND NOT RETURNED FOR EVALUATION. IT WAS IDENTIFIED THAT A LIKELY CAUSE FOR THE LEAK WAS THE PAD COMING INTO CONTACT WITH A SHARP OBJECT EITHER DURING SHIPPING OR DURING USE. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TEMPERATURE THERAPY PAD WAS FOUND TO BE LEAKING DURING PATIENT USE. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TEMPERATURE THERAPY PAD WAS FOUND TO BE LEAKING DURING PATIENT USE. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434148 TEMPERATURE THERAPY PAD PACK, HOT OR COLD, WATER CIRCULATING ILO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1