BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRA MESHED BILAYER WOUND MATRIX SIZE 2X2

    MDR report key: 14283071 · Received May 4, 2022

    Report

    Report Number
    1121308-2022-00028
    Event Type
    Injury
    Date Received
    May 4, 2022
    Report Date
    June 27, 2022
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    KGN
    PMA / PMN Number
    K081635
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D9, G3, G6, H2, H3, H6, H10.THE INTEGRA MESHED (MWM2021) WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    A FACILITY REPORTED A BILAYER WOUND MATRIX (ID MWM2021) WAS PLACED AT A FASCIAL CLOSURE SITE FOR REINFORCEMENT AT THE TIME OF A HERNIA REPAIR. THE PATIENT DEVELOPED AN ABSCESS AND REQUIRED TAKEBACK TO THE OPERATING ROOM (OR) AND MESH EXPLANTATION ONCE IT WAS DETERMINED THAT THE PRODUCT WAS INAPPROPRIATELY USED AND MAY HAVE CONTRIBUTED TO DEVELOPMENT OF THE ABSCESS.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667049 INTEGRA MESHED BILAYER WOUND MATRIX SIZE 2X2 N/A KGN INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown