BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OL 000

    MDR report key: 3503360 · Received November 19, 2013

    Report

    Report Number
    2020737-2013-00004
    Event Type
    Injury
    Date Received
    November 19, 2013
    Date of Event
    October 1, 2013
    Report Date
    November 18, 2013
    Manufacturer
    DJO, LLC
    Product Code
    LOF
    PMA / PMN Number
    P910066
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COMPLAINT RECEIVED THAT ALLEGES "PT STATES THAT HER UPPER LEFT ARM FUSED TOGETHER WITH HER SHOULDER AND WAS UNABLE TO RAISE ARM." PRODUCT NOT RETURNED FOR EVAL OR REVIEW. NO ADDITIONAL INFO RECEIVED FROM PT, AND/OR CLINICIAN REGARDING ADDITIONAL DETAILS OF INCIDENT AND/OR OBSERVATION DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598163 OL 000 BONE GROWTH STIMULATOR LOF DJO, LLC 01-211-0001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other