BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIME BIG WHEEL STRETCHER30IN

    MDR report key: 6120527 · Received November 22, 2016

    Report

    Report Number
    0001831750-2016-00372
    Event Type
    Injury
    Date Received
    November 22, 2016
    Date of Event
    October 26, 2016
    Report Date
    November 7, 2016
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE STRETCHER WAS EVALUATED FOR DEFECTS WITH THE BRAKE MECHANISM AND THE BRAKES WERE IDENTIFIED TO BE WORKING CORRECTLY AND IN ACCORDANCE WITH THE MANUAL. THERE WERE NO DEFECTS FOUND WITH THE STRETCHER. IT WAS IDENTIFIED THAT THE USER WAS INCORRECTLY ENGAGING THE BRAKES.

    Description of Event or Problem · 1

    IT WAS ALLEGED THAT WHEN A NURSE TRIED TO ENGAGE THE BRAKE ON THE DEVICE, SHE INJURED HER ANKLE. IT WAS ALLEGED THAT THE INJURY RESULTED IN A SPRAINED ANKLE REQUIRING CRUTCHES THAT WERE PRESCRIBED BY A DOCTOR WHICH SHE USED FOR A DURATION OF THREE DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773250 PRIME BIG WHEEL STRETCHER30IN STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1