BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTEGRA MESHED BILAYER WOUND MATRIX SIZE 8X10

    MDR report key: 3628674 · Received January 27, 2014

    Report

    Report Number
    1121308-2014-00003
    Event Type
    Death
    Date Received
    January 27, 2014
    Date of Event
    January 7, 2014
    Report Date
    January 22, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORP.
    Product Code
    FRO
    PMA / PMN Number
    K081635
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THIS IS THE SECOND OF TWO REPORTS CONCERNING THE SAME PATIENT (SEE MFG REPORT NUMBER: 1121308-2014-00002). THIS REPORT CONCERNS (B)(4). INTEGRA MESHED BILAYER WOUND MATRIX SIZE 8X10 LOT NUMBER 105NA0261643. IT WAS REPORTED: 'IDRT MWM WAS APPLIED TO PATIENT (55%TBSA, PBI121), BUT THE PATIENT DIED THE NEXT DAY. ((B)(6) 2014). OPERATION (BOTH DEBRIDEMENT AND APPLICATION OF IDRT) TOOK PLACE ON (B)(6), 2014, A DAY AFTER THE PATIENT ARRIVED. WITH LUNG EMPHYSEMA, PHYSIOLOGICAL CONDITION OF THE PATIENT WAS SEVERE FROM THE BEGINNING. IT WAS SEVERE ENOUGH FOR SURGEONS TO PERFORM THE OPERATION IN THE ICU, NOT IN THE OPERATING ROOM. SURGEONS DO NOT ATTRIBUTE IDRT TO PATIENT DEATH.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59329 INTEGRA MESHED BILAYER WOUND MATRIX SIZE 8X10 BWD- MESHED FRO INTEGRA LIFESCIENCES CORP. 105NA0280975

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death