BEUDAMED
    FDA Adverse Event Other Summary report: N

    BILAYER MATRIX WOUND DRESSING 2X2 SINGLE

    MDR report key: 1914466 · Received November 23, 2010

    Report

    Report Number
    1121308-2010-00028
    Event Type
    Other
    Date Received
    November 23, 2010
    Date of Event
    November 1, 2006
    Report Date
    November 23, 2010
    Manufacturer
    INTEGRA LIFESCIENCES CORP.
    Product Code
    NAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT IN 2006 A PT HAD LATERAL ANKLE SURGERY AND THE DEVICE WAS USED TO COVER HARDWARE THAT WAS IN PLACE FROM A FIBULA LENGTHENING PROCEDURE. THE PT HAD A HISTORY OF SEVERE PERIPHERAL VASCULAR DISEASE. AFTER SURGERY DURING WHICH THE PRODUCT WAS USED, THE PT HAD WELTS AND HIVES (POSSIBLE STEVENS - JOHNSON SYNDROME). THE PT LATER HAD A BELOW KNEE AMPUTATION FOR OTHER POST OPERATIVE COMPLICATIONS (THE INTEGRA MESHED BILAYER WOUND MATRIX WOULD HAVE BEEN REMOVED INCIDENTALLY DURING THIS PROCEDURE). HIS SYMPTOMS OF POSSIBLE STEVENS JOHNSON SYNDROME DID NOT RESOLVE FOLLOWING THE AMPUTATION. THE REPORTER CONSIDERS THAT THE CAUSE OF STEVENS - JOHNSON SYNDROME WAS VANCOMYCIN USE. THE PT SUBSEQUENTLY DIED OF ORGAN FAILURE. THE DOCTOR CONSIDERS THAT THE USE OF THE PRODUCT WAS NOT RELATED TO THE PT'S OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BILAYER MATRIX WOUND DRESSING 2X2 SINGLE BMWD NAD INTEGRA LIFESCIENCES CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other