BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PERMACOL PRODUCT

    MDR report key: 4085526 · Received July 9, 2014

    Report

    Report Number
    9617613-2014-00155
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Report Date
    June 10, 2014
    Manufacturer
    COVIDIEN, TISSUE SCIENCE LABORATORIES, PLC
    Product Code
    FTL
    PMA / PMN Number
    K992556
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    LITERATURE REVIEW: IN AN ARTICLE ENTITLED "A RETROSPECTIVE STUDY EVALUATING THE USE OF PERMACOL SURGICAL IMPLANT IN INCISIONAL AND VENTRAL HERNIA REPAIR" WRITTEN BY BIPAN CHAND ET. AL. PUBLISHED IN INTERNATIONAL JOURNAL OF SURGERY XXX (2014) 1-8. A RETROSPECTIVE STUDY LOOKED AT 343 PATIENTS TREATED FOR INCISIONAL AND VENTRAL HERNIAS. TWENTY PATIENTS WERE NOTED TO HAVE HERNIA RECURRENCES AT THE 1 YEAR F/U MARK. THREE PATIENTS WERE NOTED TO HAVE SEVERE POST-DISCHARGE DEVICE RELATED COMPLICATIONS: SEROMA, WOUND DEHISCENCE, AND TEARING OF MESH. THERE WAS ONE CASE OF IMPLANT OSSIFICATION OF MODERATE SEVERITY. THERE WERE TWO PATIENTS WHO EXPERIENCED NON-HERNIA BULGE OF MODERATE SEVERITY POSSIBLY DUE TO IMPLANT LAXITY. THERE WAS ONE PATIENT WHO REQUIRED REOPERATION FOR MESH EXPLANTATION WHICH WAS NOTED TO BE PROCEDURE-RELATED. THIS IS FOR ONE OF THE PATIENTS WHO EXPERIENCED RECURRENCE OF THE HERNIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399171 UNKNOWN PERMACOL PRODUCT NONE FTL COVIDIEN, TISSUE SCIENCE LABORATORIES, PLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1