BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMACOL 15X20 1.5MM

    MDR report key: 3093896 · Received April 24, 2013

    Report

    Report Number
    9617613-2013-00178
    Event Type
    Injury
    Date Received
    April 24, 2013
    Report Date
    March 27, 2013
    Manufacturer
    COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES
    Product Code
    FTL
    PMA / PMN Number
    K992556
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: ELECTIVE COLOSTOMY TAKE DOWN WITH VENTRAL HERNIA REPAIR. ACCORDING TO THE REPORTER: A PERMACOL GRAFT USED TO REPAIR HERNIA. APPROX SIX WEEKS POST OPERATIVELY, THE PT PRESENTED WITH DRAINAGE THROUGH SMALL OPENING IN INCISION. THE DRAINAGE WOULD NOT STOP AND THE PT WAS TAKEN TO THE OPERATING ROOM. THE INCISION WAS RE-OPENED WHICH LEAD TO LARGE CAVITY OF LIQUEFIED GRAFT. THE WOUND WAS DEBRIDED AND A WOUND VAC WAS PLACED. THE SURGEON STATED THAT HE DID NOT PLACE DRAINS AFTER INITIAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176624 PERMACOL 15X20 1.5MM PERMACOL MESH FTL COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES 11B1308

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other