BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNAMIC PACER

    MDR report key: 5813585 · Received July 21, 2016

    Report

    Report Number
    1319061-2016-00001
    Event Type
    Injury
    Date Received
    July 21, 2016
    Date of Event
    June 30, 2016
    Report Date
    June 30, 2016
    Manufacturer
    RIFTON EQUIPMENT
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER INDICATED THAT IT IS NOT CLEAR THAT THE EVENT HAPPENED AS A RESULT OF USING THE DYNAMIC PACER. THERE WAS NO APPARENT MALFUNCTION OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLIENT WAS USING THE DYNAMIC PACER WITH THE MULTI POSITION SADDLE ACCESSORY WHEN SOME OF THE CLIENT'S TESTICLE GOT PUSHED UP INSIDE, REQUIRING MEDICAL ASSISTANCE TO GET IT OUT AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464581 DYNAMIC PACER GAIT TRAINER ITJ RIFTON EQUIPMENT K640

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention