BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM204 M-SERIES W/BIG WHEEL

    MDR report key: 1972308 · Received December 30, 2010

    Report

    Report Number
    1831750-2010-05399
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 3, 2010
    Manufacturer
    STRYKER CORP., MEDICAL DIVISION
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: CORNER CRACKED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THE SERVING TRAYS HAVE CRACKS ON THE CORNERS RESULTING IN SHARP EDGES. NO PATIENT 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 CORP., MEDICAL DIVISION 1015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK