BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEG WRAP BLANKET

    MDR report key: 3193129 · Received June 27, 2013

    Report

    Report Number
    0001831750-2013-05854
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 2, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    ILO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL AND FUNCTIONAL INSPECTION WAS ALLEGEDLY PERFORMED BY A CUSTOMER REPRESENTATIVE FROM THE USER FACILITY. THE ALLEGED INSPECTION FOUND THAT THE LEG WRAP HAD LEAKED. AFTER CONTACTING THE CUSTOMER IT WAS CONFIRMED THAT THE LEG WRAP WAS DISPOSED OF AND NOT AVAILABLE FOR FURTHER EVALUATION OR FURTHER INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEG WRAP 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 LEG WRAP 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
    292989 LEG WRAP BLANKET PACK, HOT OR COLD, WATER CIRCULATING ILO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1