BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIME BIG WHEEL STRETCHER

    MDR report key: 6048912 · Received October 21, 2016

    Report

    Report Number
    0001831750-2016-00331
    Event Type
    Injury
    Date Received
    October 21, 2016
    Date of Event
    September 1, 2015
    Report Date
    January 11, 2017
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO COMPONENT LEVEL DEFECT WAS ALLEGED WITH THE DEVICE. THE NURSE RUPTURED (TORE) HER PLANTAR PLATE (TOE LIGAMENT) IN HER FOOT AND RECEIVED MEDICAL ATTENTION. THE SERIAL NUMBER OF THE DEVICE COULD NOT BE IDENTIFIED. THE SALES ACCOUNT MANAGER DISCUSSED PROPER ERGONOMICS AND TRAINING WHEN ACTIVATING THE BRAKE/STEER PEDAL ON THESE DEVICES. THE CUSTOMER WAS UNABLE TO IDENTIFY THE DEVICE.

    Description of Event or Problem · 1

    IT WAS ALLEGED THAT WHILE ATTEMPTING TO ENGAGE/DISENGAGE THE BRAKES OF THE DEVICE, A (B)(6) NURSE RUPTURED HER PLANTAR PLATE IN HER FOOT. IT WAS ALLEGED THAT SHE SOUGHT MEDICAL ATTENTION AS A RESULT OF THE ALLEGED EVENT.

    Description of Event or Problem · 1

    IT WAS ALLEGED THAT WHILE ATTEMPTING TO ENGAGE/DISENGAGE THE BRAKES OF THE DEVICE, A (B)(6) NURSE RUPTURED HER PLANTAR PLATE IN HER FOOT. IT WAS ALLEGED THAT SHE SOUGHT MEDICAL ATTENTION AS A RESULT OF THE ALLEGED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698103 PRIME BIG WHEEL STRETCHER STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1