BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM204 M-SERIES W/BIG WHEEL

    MDR report key: 2004038 · Received February 7, 2011

    Report

    Report Number
    1831750-2011-01163
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 10, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION IS UNDERWAY.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED BY (B)(6) HOSP THAT STAINING HAS OCCURRED ON THREE OF THEIR (B)(4) ULTRA MATTRESSES. ACCORDING TO THE FACILITY, THEY CLEAN THEM WITH PDI SUPER SEMI CLOTH. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SM204 M-SERIES W/BIG WHEEL HOSPITAL WHEELED STRETCHER FPO STRYKER MEDICAL 1015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK