BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OFF-LOADING DIABETIC SHOE, M

    MDR report key: 3213392 · Received June 13, 2013

    Report

    Report Number
    9616086-2013-00011
    Event Type
    Injury
    Date Received
    June 13, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 13, 2013
    Manufacturer
    DJO, LC
    Product Code
    KNP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COMPLAINT RECEIVED STATING THAT "CAUSED ULCER ON TOE AND PATIENT ENDED UP HAVING TOE AMPUTATED." PRODUCT NOT RETURNED FOR EVALUATION OR REVIEW. NO ADDITIONAL INFORMATION RECEIVED FROM PATIENT, AND/OR CLINICIAN REGARDING ADDITIONAL DETAILS OF INCIDENT. COMPLAINT INDICATED EVENT CAUSED OR CONTRIBUTED TO PERMANENT IMPAIRMENT, INJURY, OR DEATH. UNABLE TO CONFIRM IF DEVICE CAUSED OR CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269715 OFF-LOADING DIABETIC SHOE, M KNP DJO, LC 79-81515

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability