BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PERMACOL PRODUCT

    MDR report key: 3627945 · Received February 6, 2014

    Report

    Report Number
    9617613-2014-00091
    Event Type
    Injury
    Date Received
    February 6, 2014
    Report Date
    January 6, 2014
    Manufacturer
    COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: VENTRAL HERNIA REPAIR. ACCORDING TO THE REPORTER: AN ARTICLE TITLED BIOLOGIC MESH IN A CONTAMINATED FIELD: INFECTED MESH REMOVAL AND HERNIA REPAIR IN A SINGLE-STAGE, IN SSAT ABSTRACTS, S-1058, STATES A COMPARISON OF PERMACOL AND ALLODERM WAS CONDUCTED IN PTS WHO UNDERWENT A SINGLE STAGE INCISIONAL HERNIA REPAIR WITH REPLACEMENT OF AN INFECTED SYNTHETIC MESH BY A BIOLOGIC MESH AT (B)(6). FORTY-ONE PTS WERE INCLUDED IN THE STUDY, WITH TWENTY PTS RECEIVING PERMACOL. OF THE PERMACOL COMPLICATIONS, SEVEN HAD A RECURRENCE OF HERNIA. THIS REPORT IS FOR ONE OF THOSE RECURRENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77263 UNKNOWN PERMACOL PRODUCT NONE FTL COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other