BEUDAMED
    FDA Adverse Event Death Summary report: N

    IDRT-TS (INTL) SINGLE 4X5

    MDR report key: 4257383 · Received November 14, 2014

    Report

    Report Number
    1121308-2014-00071
    Event Type
    Death
    Date Received
    November 14, 2014
    Date of Event
    August 12, 2014
    Report Date
    October 19, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORP.
    Product Code
    MGR
    PMA / PMN Number
    P900033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AFTER 15 TO 20 DAYS OF INTEGRA DERMAL REGENERATION TEMPLATE (DRT) IMPLANTATION ON A (B)(6) MALE PATIENT BURNED AFTER A GAS BOTTLE EXPLOSION, THE PATIENT DIED. ON AUTOPSY REPORT, IT STATED THAT THE PATIENT DIED FROM BURNS (OVER 30% OF HIS BODY WAS BURNED) WHICH ALSO CAUSED SEPSIS. THERE WAS CONFIRMATION THAT EVERYTHING WAS OK WITH THE PLACED IDRT. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2014 WITH THE FOLLOWING: DATE OF DEATH WAS ON (B)(6) 2014. THE IDRT WAS IMPLANTED ON (B)(6) 2014. THE PATIENT HAD 30% BURNS OVER HIS BODY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737937 IDRT-TS (INTL) SINGLE 4X5 IDRT-TS MGR INTEGRA LIFESCIENCES CORP. 105NB0299336

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Death