BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK PERMACOL PRODUCT

    MDR report key: 4078280 · Received July 8, 2014

    Report

    Report Number
    9617613-2014-00112
    Event Type
    Malfunction
    Date Received
    July 8, 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
    PHYSICIAN

    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 PERCENT 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 PERCENT) PATIENTS HAD MORE THAN ONE COMPLICATION IN THE POSTOPERATIVE PERIOD. THE MOST COMMON COMPLICATIONS INCLUDED INFECTION (13 PERCENT) AND RECURRENCE (12 PERCENT). THIS IS FOR ONE OF THE PATIENTS WHO EXPERIENCED A RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395829 UNK PERMACOL PRODUCT NONE FTL COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1