BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXOGEN

    MDR report key: 2080424 · Received May 6, 2011

    Report

    Report Number
    1020279-2011-00150
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    April 20, 2011
    Report Date
    May 6, 2011
    Manufacturer
    SMITH & NEPHEW, ORTHOPEDICS
    Product Code
    LPQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DEVELOPED A MILD SKIN IRRITATION WHILE USING THE EXOGEN DEVICE. IT WAS NOTED BY THE TREATING THE PATIENT DID FOLLOW USAGE INSTRUCTIONS. THE DEVICE WAS NOT FAULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXOGEN BONE GROWTH STIMULATOR LPQ SMITH & NEPHEW, ORTHOPEDICS EXOGEN 4000+ SYSTEM 0910051106E

    Patients

    Seq Age Sex Outcome Treatment
    1 Other