BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIME 5TH WHEEL STRETCHER 26IN

    MDR report key: 11293448 · Received February 8, 2021

    Report

    Report Number
    0001831750-2021-00529
    Event Type
    Malfunction
    Date Received
    February 8, 2021
    Date of Event
    January 14, 2021
    Report Date
    February 8, 2021
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    UDI-DI
    07613327278149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT MAKE THE DEVICE AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BRAKES NEEDED TO BE REPAIRED. THE REPAIR WAS CANCELLED BY THE CUSTOMER WITHOUT THE REPORTED ISSUE BEING CONFIRMED. 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
    193143 PRIME 5TH WHEEL STRETCHER 26IN STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO 1105 07613327278149

    Patients

    Seq Age Sex Outcome Treatment
    1