BEUDAMED
    FDA Adverse Event Other Summary report: N

    MIAMI J COLLAR

    MDR report key: 1689190 · Received May 7, 2010

    Report

    Report Number
    2242474-2010-00001
    Event Type
    Other
    Date Received
    May 7, 2010
    Date of Event
    February 12, 2010
    Report Date
    May 7, 2010
    Manufacturer
    OSSUR AMERICAS
    Product Code
    IQK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE INVESTIGATED THIS ISSUE BOTH INTERNALLY AND WITH ALL OF OUR PERTINENT SUPPLIERS FOR THE MIAMI J COLLAR. NEITHER OSSUR NOR ITS SUPPLIERS USES EITHER OF THOSE CHEMICAL FORMULATIONS IN THE PROCESSING/FABRICATION OF THE MIAMI J OR ITS COMPONENT PARTS. AS A RESULT, IT DOES NOT APPEAR THAT THE MIAMI J WAS EXPOSED TO EITHER OF THESE FORMULATIONS DURING OUR OR OUR SUPPLIERS' PROCESSING.

    Description of Event or Problem · 1

    AFTER SURGERY, THE PT WORE OUR MIAMI J BRACE ON HIS NECK. AFTER REMOVING THE BRACE, THE DOCTOR NOTICED A THIN LINE OF HYPOPIGMENTATION. THE COLOR RETURNED TO THE PT'S SKIN, BUT THE DOCTOR MAILED A LETTER TO US NOTING THE EVENT AND ASKING FOR AN EVALUATION OF THE PRODUCT TO DETERMINE IF THE FOLLOWING SUBSTANCES WERE IN THE PRODUCT: 4-TERT-BUTYLCATECHOL AND TRIGLYCIDYL ISOCYANURATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIAMI J COLLAR IQK OSSUR AMERICAS MJ-400

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other