BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_MEDICAL_PRODUCT

    MDR report key: 3016380 · Received March 22, 2013

    Report

    Report Number
    0001831750-2013-02274
    Event Type
    Malfunction
    Date Received
    March 22, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FMW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS INITIALLY REPORTED THAT THE MATTRESS WAS STAINED FROM FLUID INGRESS. FOLLOW-UP SUBMITTED AS FURTHER INVESTIGATION DETERMINED THE DISCOLORATION WAS DUE TO ADHESIVE OXIDATION. THIS IS NOT LIKELY TO HARM THE PATIENT AS NO MATTRESS FUNCTION WAS AFFECTED. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED. THIS ISSUE IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH IF IT WAS TO RECUR.

    Additional Manufacturer Narrative · 1

    UNIT WILL BE SCRAPPED BY CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE MATTRESS FOAM HAD FLUID INGRESS. 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 VIA REPAIR WORK ORDER THAT THE MATTRESS FOAM HAD FLUID INGRESS. 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
    120832 UNKNOWN_MEDICAL_PRODUCT UNKNOWN FMW STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1