BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DONJOY

    MDR report key: 6210399 · Received December 28, 2016

    Report

    Report Number
    9616086-2016-00029
    Event Type
    Injury
    Date Received
    December 28, 2016
    Date of Event
    November 8, 2015
    Report Date
    December 28, 2016
    Manufacturer
    DJO, LLC
    Product Code
    ITQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RETURNED.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED THAT ALLEGES " AFTER WEARING THIS BRACE FOR 1 MONTH, THE PATIENT HAD TO GO TO THE HOSPITAL BETWEEN (B)(6) 2015 BECAUSE OF A LESION OF THE PERONEAL NERVE. THE HOSPITAL WROTE A LETTER CONFIRMING THAT THIS LESION OF THE PERONEAL NERVE WAS INDUCED BY OUR DONJOY LEGEND BRACE". QUESTIONNAIRE WAS RECEIVED FROM CUSTOMER OR CLINICIAN. QUESTIONNAIRE INDICATES THAT ON (B)(6) 2015, THE PATIENT SUFFERED A "LESION OF THE PERONEAL NERVE" WHILE WEARING THE BRACE. SHAPE OF BRACE, AND STRAP LENGTH HAD BEEN ALTERED FOR THE PATIENT. PATIENT WAS HOSPITALIZED FOR INJURY, TYPE OF TREATMENT UNKNOWN. DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860653 DONJOY LEGEND ITQ DJO, LLC 11-0453-4-06060

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O