BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMACOL 15X20 1.5MM

    MDR report key: 2133717 · Received June 9, 2011

    Report

    Report Number
    9617613-2011-00016
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    April 30, 2011
    Report Date
    May 18, 2011
    Manufacturer
    TISSUE SCIENCE LABORATORIES, PLC
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: COSMETIC. ACCORDING TO THE REPORTER: (B)(6) POST-OPERATIVELY, WOUND DEHISCENCE OF THE SKIN WAS NOTED WHICH LEAVES THE IMPLANT EXPOSED TO AIR. IT IS BEING KEPT HYDRATED USING GAUZES SOAKED IN SALINE SOLUTION AND (B)(6), THE OPENING OF THE WOUND INCREASED (BECAME WIDER) AS WAS ALSO NOTED THE ABSENCE OF THE MESH IN SOME AREAS OF THE IMPLANT, LOOKING LIKE IT IS BEING REABSORBED. THE PATIENT WAS RE-OPERATED AFTER (B)(6) AND THERE WAS NOT ANY INTEGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMACOL 15X20 1.5MM TSL PERMACOL FTL TISSUE SCIENCE LABORATORIES, PLC 09B30-9

    Patients

    Seq Age Sex Outcome Treatment
    1 Other