BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DONJOY

    MDR report key: 5001025 · Received August 5, 2015

    Report

    Report Number
    9616086-2015-00021
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    July 2, 2015
    Report Date
    August 5, 2015
    Manufacturer
    DJO, LLC
    Product Code
    ITQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REPORT NUMBER NEEDS TO BE UPDATE TO (B)(4) AS (B)(4) INCLUDES THE INCORRECT MANUFACTURER REGISTRATION NUMBER. DEVICE MANUFACTURED BY (B)(4). REGISTRATION NUMBER (B)(4). NOT RETURNED

    Description of Event or Problem · 1

    PER 21 CFR 803, AN MDR REPORTABLE EVENT, COMPLAINT RECEIVED THAT ALLEGES "REPORT THAT SHE WAS WALKING AND THE DROPLOCK HINGE DIS-ENGAGED AND SHE FELL TO THE FLOOR AND BROKE HER NOSE AND GLASSES." PRODUCT NOT RETURNED FOR EVALUATION OR REVIEW. NO ADDITIONAL INFORMATION RECEIVED FROM PATIENT OR CLINICIAN REGARDING ADDITIONAL DETAILS OF INCIDENT. NO INDICATION OF DEVICE CAUSE OR CONTRIBUTION TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517632 DONJOY DEFIANCE DROPLOCK KNEE BRACE ITQ DJO, LLC CONV DEFIANCE DROPLOCK 20140926153 R00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention