BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAISSANCE 29 STRETCHER 8/00

    MDR report key: 3132890 · Received May 29, 2013

    Report

    Report Number
    0001831750-2013-04838
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE CORNER COVER WAS MISSING, RESULTING IN SHARP EDGES BEING EXPOSED. PATIENT ALLEGEDLY CUT THEIR LEG; HOWEVER, NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236362 RENAISSANCE 29 STRETCHER 8/00 STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1