BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILAYER MATRIX WOUND DRESSING 8X10 SINGLE

    MDR report key: 1935436 · Received November 10, 2010

    Report

    Report Number
    1121308-2010-00025
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 14, 2010
    Report Date
    November 10, 2010
    Manufacturer
    INTEGRA LIFESCIENCES CORP.
    Product Code
    NAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT WHEN THE BILAYER MATRIX WOUND DRESSING ORDER WAS RECEIVED AT THE USER FACILITY, ONE OF THE TEN PIECES WAS OBSERVED TO HAVE WET (B)(4) AT THE PACKAGE SEAL AREA. IT IS CONSIDERED POSSIBLE THAT THE PACKAGING MAY BE LEAKING AND THAT STERILITY OF THE CONTENTS OF THE ONE ITEM MAY BE COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BILAYER MATRIX WOUND DRESSING 8X10 SINGLE BMWD NAD INTEGRA LIFESCIENCES CORP. 105A00193692

    Patients

    Seq Age Sex Outcome Treatment
    1