BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE SERIES 26 OBS 10/04

    MDR report key: 3073224 · Received April 23, 2013

    Report

    Report Number
    0001831750-2013-03671
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 28, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS EVALUATED UNIT AND DETERMINED THAT THERE IS NO MALFUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXITED THE STRETCHER THROUGH THE FRONT END AND THE STRETCHER TIPPED. THE CAREGIVER HELPED TO PREVENT THE PATIENT FROM FALLING; HOWEVER, THE CAREGIVER STRAINED THEIR BACK AS A RESULT AND REQUIRED PHYSICAL THERAPY. THE CUSTOMER EVALUATED THE UNIT AND COULD NOT FIND, NOR ARE CLAIMING, A MALFUNCTION. THIS WAS THE RESULT OF USER ERROR, AS THE STRYKER MANUAL STATES THAT PATIENTS SHOULD EXIT THE STRETCHER FROM THE SIDE, AND NOT THE FRONT OF THE STRETCHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175214 ADVANTAGE SERIES 26 OBS 10/04 STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1