BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPERATURE THERAPY PAD

    MDR report key: 2135224 · Received June 14, 2011

    Report

    Report Number
    1313850-2011-00139
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    STRYKER CORP DBA GAYMAR
    Product Code
    FOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: INTERNAL BUTTON WELDS HAVE PEELED, CAUSING THE MATERIAL TO STRETCH AND FORM HOLES. CONCLUSION: CUSTOMER REQUESTED CREDIT FOR PAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PAD APPEARED TO HAVE A BLOCKAGE AND IT WOULD NOT ALLOW WATER TO FLOW THROUGH THE ENTIRE PAD. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED. CUSTOMER STATED THAT THE PAD APPEARED TO HAVE A BLOCKAGE IN. IT WOULDN'T LET WATER FLOW THROUGH THE WHOLE PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEMPERATURE THERAPY PAD TEMPERATURE THERAPY PAD FOH STRYKER CORP DBA GAYMAR TP22G NA

    Patients

    Seq Age Sex Outcome Treatment
    1