BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PERMACOL PRODUCT

    MDR report key: 3281000 · Received August 2, 2013

    Report

    Report Number
    9617613-2013-00647
    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 TRAVELS 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 TWO PTS WHO SUFFERED AN OESOPHAGEAL PERFORATION, WHO WAS TREATED CONSERVATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363960 UNKNOWN PERMACOL PRODUCT PERMACOL MESH FTL COVIDIEN, FORMERLY TISSUE SCIENCE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other