BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIME 5TH WHEEL STRETCHER, 26"

    MDR report key: 2063337 · Received April 11, 2011

    Report

    Report Number
    1831750-2011-03463
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE RIGHT TOP RAIL WAS BROKEN PRODUCING A SHARP EDGE ON THE RAIL. THERE WAS PATIENT INVOLVEMENT; HOWEVER, IT WAS UNKNOWN IF THERE WERE ANY ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIME 5TH WHEEL STRETCHER, 26" HOSPITAL WHEELED STRETCHER FPO STRYKER MEDICAL 1105000026 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK