BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAGEN PLUS, UNKNOWN

    MDR report key: 2499506 · Received March 16, 2012

    Report

    Report Number
    1121308-2012-00010
    Event Type
    Injury
    Date Received
    March 16, 2012
    Report Date
    March 16, 2012
    Manufacturer
    INTEGRA LIFESCIENCES CORP.
    Product Code
    GXQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE REPORTED INFO, THE FINDINGS WERE AS FOLLOWS: THE REPORTED CONDITION COULD NOT BE CONFIRMED. INFO REGARDING THE LOT NUMBER OF THE PRODUCT WAS NOT REPORTED. THE PRODUCT WAS NOT RETURNED FOR EVAL. HENCE, THE ROOT CAUSE COULD NOT BE DETERMINED. INTEGRA CONSIDERS THIS COMPLAINT INVESTIGATION CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FOREIGN BODY REACTION HAD OCCURRED WITH THE PT. DURAGEN PLUS HAD BEEN IMPLANTED. DURASEAL WAS USED IN CONJUNCTION WITH THE DURAGEN PLUS. THE SIZE OF THE DURAGEN PLUS WAS NOT REPORTED. IT WAS REPORTED THAT THE SURGEON DID NOT WANT TO TAKE THE COMPLAINT FURTHER AT THIS TIME. ALL FURTHER PT INFO, PROCEDURE DATES, AND PRODUCT DETAILS WILL NOT BE PROVIDED. NO OTHER INFO WILL BE EXPECTED TO BE RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAGEN PLUS, UNKNOWN NA GXQ INTEGRA LIFESCIENCES CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1