BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    PRIME 5TH WHEEL STRETCHER 30IN

    MDR report key: 7453148 · Received April 23, 2018

    Report

    Report Number
    0001831750-2018-00279
    Event Type
    Malfunction
    Date Received
    April 23, 2018
    Date of Event
    December 2, 2017
    Report Date
    April 23, 2018
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    UDI-DI
    07613327278156
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS PART OF THE MALFUNCTION SUMMARY REPORTING PROGRAM, EXEMPTION NUMBER E2014007. THE DEVICE WAS EVALUATED IN THE FIELD AND THE ISSUE WAS NOT CONFIRMED. THERE WERE NO REMEDIAL ACTIONS TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE 5TH WHEEL WAS DIFFICULT TO ENGAGE/DISENGAGE. NOT PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293849 PRIME 5TH WHEEL STRETCHER 30IN STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO 07613327278156

    Patients

    Seq Age Sex Outcome Treatment
    1