BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIME 5TH WHEEL STRETCHER 30IN

    MDR report key: 11195656 · Received January 19, 2021

    Report

    Report Number
    0001831750-2021-00069
    Event Type
    Malfunction
    Date Received
    January 19, 2021
    Date of Event
    January 6, 2021
    Report Date
    January 19, 2021
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    UDI-DI
    07613327278156
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STEER MECHANISM IS DIFFICULT TO ENGAGE/DISENGAGE. 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
    92125 PRIME 5TH WHEEL STRETCHER 30IN STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO 1105 07613327278156

    Patients

    Seq Age Sex Outcome Treatment
    1