BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIFLEX III PKG

    MDR report key: 1161194 · Received September 15, 2008

    Report

    Report Number
    1022819-2008-00255
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    August 15, 2008
    Report Date
    August 15, 2008
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    BXB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURE IS AWAITING THE RETURN OF THE DEVICE FOR EVALUATION. THE DEVICE EVALUATION AND ANY ADDITIONAL FINDINGS WILL BE PROVIDED UPON CONCLUSION OF THE DEVICE EVALUATION.

    Description of Event or Problem · 1

    CLINICIAN RECEIVED A SKIN SHOCK FROM AN OPTIFLEX III KNEE EXERCISE DEVICE DURING A PATIENT KNEE EXERCISE TREATMENT. THE PATIENT HAD RECEIVED THERAPY USING THE OPTIFLEX III THREE TO FOUR TIMES PREVIOUS TO THIS EVENT. THE PATIENT WAS RECEIVING KNEE EXERCISE THERAPY WHEN THE DEVICE STARTED TO SHOCK THE PATIENT. THE CLINICIAN STOPPED THE TREATMENT AND REMOVED THE PATIENT'S LEG FROM THE DEVICE. AS THE CLINICIAN WAS REMOVING THE DEVICE, THE CLINICIAN RECEIVED A SHOCK FROM THE DEVICE. THE CLINICIAN REPORTED THAT NO INJURIES RESULTED FROM THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIFLEX III PKG BXB CHATTANOOGA GROUP 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention