BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERMACOL

    MDR report key: 855337 · Received May 23, 2007

    Report

    Report Number
    9617613-2007-00012
    Event Type
    Other
    Date Received
    May 23, 2007
    Date of Event
    April 24, 2007
    Report Date
    May 23, 2007
    Manufacturer
    TISSUE SCIENCE LABORATORIES PLC
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING A REVIEW OF THE DEVICE HISTORY RECORD FOR 05B16-9 ALL PROCESS AND TEST CRITERIA HAS BEEN VERIFIED AS COMPLYING WITH THE PERMACOL FINISHED PROD SPECIFICATION. THE INVESTIGATION CONCLUDED SATISFACTORY PROCESSING AND PACKAGING OF TISSUE AND RESULTANT TESTING OF PROD. THERE WAS NO EVIDENCE TO SUGGEST ANY REASON FOR POTENTIAL PROD ABSORPTION, STERILITY OR TENSILE STRENGTH CONCERNS. THE PERMACOL WAS MANAGED IN AN OPEN WOUND ENVIRONMENT WHICH TSL DO NOT PROMOTE NOR RECOMMEND.

    Description of Event or Problem · 1

    TWO PIECES OF PERMACOL WERE SUTURED TOGETHER AND PLACED IN AN OPEN WOUND ENVIRONMENT. FOLLOWING IMPLANTATION SUTURE PULL-THROUGH OCCURRED WHICH RESULTED IN REMOVAL OF THE PERMACOL IMPLANT IN THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMACOL PORCINE DERMAL IMPLANT FTL TISSUE SCIENCE LABORATORIES PLC NA 05B16-9 X 2

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other