BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    PRIME BIG WHEEL STRETCHER 26IN

    MDR report key: 9637979 · Received January 28, 2020

    Report

    Report Number
    0001831750-2020-00248
    Event Type
    Malfunction
    Date Received
    January 28, 2020
    Date of Event
    January 1, 2020
    Report Date
    March 20, 2020
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    UDI-DI
    07613327278231
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS ORIGINALLY REPORTED THE DEVICE HAD BRAKES THAT WERE DIFFICULT TO ENGAGE AND WOULDN'T HOLD; HOWEVER, UPON INSPECTION OF THE DEVICE IT WAS DETERMINED THERE WAS NO MALFUNCTION WITH THE BRAKES.

    Additional Manufacturer Narrative · 1

    THIS MDR IS A CONSOLIDATION OF RECORDS SUMMARIZED AS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THE DEVICE IS PENDING EVALUATION. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT, WHERE IT WAS REPORTED THE BRAKES WERE DIFFICULT TO ENGAGE AND WOULDN'T HOLD. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT, WHERE IT WAS REPORTED THE BRAKES WERE DIFFICULT TO ENGAGE AND WOULDN'T HOLD. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT, WHERE IT WAS REPORTED . THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101309 PRIME BIG WHEEL STRETCHER 26IN STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO 1115 07613327278231

    Patients

    Seq Age Sex Outcome Treatment
    1