BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMACOL 20X30 1.5MM

    MDR report key: 2031059 · Received March 16, 2011

    Report

    Report Number
    9617613-2011-00007
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    November 16, 2010
    Report Date
    February 15, 2011
    Manufacturer
    TISSUE SCIENCE LABORATORIES, PLC
    Product Code
    FTL
    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

    PROCEDURE TYPE: HERNIA. ACCORDING TO THE REPORTER: MICROSURGICAL PROBLEMS OCCURRED 30 HOURS POST-OPERATIVELY AND HAD TO PERFORM A REVISION OF THE ANASTOMOSIS ON (B)(6) 2010. NECROSIS OF MUSCLE PART OF FLAP LEADS TO DEBRIDEMENT PROCEDURES ON (B)(6). THE PT WAS TREATED WITH VACUUM THERAPY, IMPLANT WAS FRAGILE AND WAS REMOVED AND REPLACED ON (B)(6). PT EXPERIENCED SEPTIC CONSTELLATION AND FLAP NECROSIS AND REVISION WAS PERFORMED ON (B)(6) 2010 FOLLOWED BY PLANNED REVISIONS ON (B)(6), IMPLANT REMOVED STEP BY STEP. ANOTHER MESH WAS SUTURED IN POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMACOL 20X30 1.5MM TSL PERMACOL IMPLANT FTL TISSUE SCIENCE LABORATORIES, PLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other