BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PERMACOL PRODUCT

    MDR report key: 3280973 · Received August 2, 2013

    Report

    Report Number
    9617613-2013-00651
    Event Type
    Injury
    Date Received
    August 2, 2013
    Report Date
    July 11, 2013
    Manufacturer
    COVIDIEN, FORMERLY TISSUE SCIENCE
    Product Code
    FTL
    PMA / PMN Number
    K992556
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: HERNIA. ACCORDING TO TRAVERS ET AL. IN THE ABSTRACT ENTITLED SELECTIVE USE OF BIOLOGICAL MESH FOR TENSION FREE REPAIR OF COMPLEX AND RECURRENT PARAOESOPHAGEAL HERNIA PRESENTED RESULTS OF A STUDY THAT EVALUATED THE EFFICACY OF INTEGRATING A PORCINE DERMAL COLLAGEN MESH (PERMACOL) TO CREATE A TENSION-FREE REPAIR. THE STUDY LOOKED AT PTS FROM (B)(6) 2004 TO (B)(6) 2012. THERE WERE 43 PTS WHO UNDERWENT MESH REINFORCED PEH REPAIR. IN TOTAL THERE WERE 5 COMPLICATIONS. THERE WERE TWO PTS WHO SUFFERED OESOPHAGEAL PERFORATIONS. THERE WERE TWO PTS WHO DEVELOPED INPATIENT POST-OPERATIVE PARTIAL RECURRENCE. BOTH UNDERWENT SUCCESSFUL SURGICAL RE-INTERVENTION. POSTOPERATIVELY AT 37 MONTHS, 1 PT HAD CONFIRMED RECURRENCE REQUIRING REVISIONAL SURGERY. THIS IS FOR ONE OF THE PT WHO DEVELOPED POST-OPERATIVE RECURRENCE AT 37 MONTHS AND UNDERWENT SUCCESSFUL SURGICAL RE-INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364126 UNKNOWN PERMACOL PRODUCT PERMACOL MESH FTL COVIDIEN, FORMERLY TISSUE SCIENCE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other