BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PERMACOL PRODUCT

    MDR report key: 4085549 · Received July 9, 2014

    Report

    Report Number
    9617613-2014-00133
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC
    Product Code
    FTL
    PMA / PMN Number
    K992556
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    LITERATURE REVIEW: IN AN ARTICLE ENTITLED, OUTCOME OF ABDOMINAL WALL HERNIA REPAIR WITH PERMACOL BIOLOGIC MESH, WRITTEN BY TALAR TEGIRIAN ET AL PUBLISHED IN THE AMERICAN SURGEON IN OCTOBER 2013. A RETROSPECTIVE REVIEW WAS CONDUCTED INCLUDING ALL ADULT PATIENTS WHO UNDERWENT ABDOMINAL WALL HERNIA REPAIR WITH PERMACOL BETWEEN OCTOBER 2007 AND JULY 2011. ONE HUNDRED NINETY-FIVE PATIENTS (56% FEMALES, MEAN AGE 61 YEARS) HAD ABDOMINAL WALL PLACEMENT OF PERMACOL DURING THE STUDY PERIOD. THE OVERALL COMPLICATION RATE WAS 39.5 PERCENT (N 4 77); NINE (5%) PATIENTS HAD MORE THAN ONE COMPLICATION IN THE POSTOPERATIVE PERIOD. THE MOST COMMON COMPLICATIONS INCLUDED INFECTION (13%) AND RECURRENCE (12%). THIS IS FOR ONE OF THE PATIENTS WHO EXPERIENCED A RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399165 UNKNOWN PERMACOL PRODUCT UNK FTL COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1