BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIME 5TH WHEEL STRETCHER, 30"

    MDR report key: 3031552 · Received April 2, 2013

    Report

    Report Number
    0001831750-2013-02838
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 7, 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 LITTER SEAT SECTION ASSEMBLY WAS BENT AND CRACKED. SHARP EDGES WERE ACCESSIBLE. 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
    134638 PRIME 5TH WHEEL STRETCHER, 30" STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1