BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PERMACOL PRODUCT

    MDR report key: 3713615 · Received March 18, 2014

    Report

    Report Number
    9617613-2014-00098
    Event Type
    Injury
    Date Received
    March 18, 2014
    Date of Event
    November 18, 2010
    Report Date
    March 7, 2014
    Manufacturer
    COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC
    Product Code
    FTL
    PMA / PMN Number
    K992556
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DR (B)(6) FROM THE CLINIC REPORTED AS FOLLOWS: (B)(6) GIRL HAD SURGERY OF OMPHALOCELE REPAIR IN 2010 WITH PERMACOL. THERE WERE REPEATEDLY INFLAMMATORY REACTIONS WHICH WERE TREATED WITH DRAINAGES AND LATER WITH VAC THERAPIES. (B)(6) 2013 THE WOUND WAS REOPENED AND A PART OF THE PERMACOL MESH WAS REMOVED, THERE WAS ANOTHER SURGERY IN (B)(6) 2014. DR (B)(6) SAID THAT HE HAS TO REMOVE PARTS OF THE MESH WHICH ARE LOCATED IN A THIN LAYER. THERE IS PLANNED A FINAL SURGERY IN ORDER TO REMOVE THE WHOLE PERMACOL IMPLANT SOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157744 UNKNOWN PERMACOL PRODUCT NONE FTL COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other