BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMACOL 20X30 1.5MM

    MDR report key: 3003923 · Received December 9, 2008

    Report

    Report Number
    9617613-2008-00014
    Event Type
    Injury
    Date Received
    December 9, 2008
    Date of Event
    October 24, 2008
    Report Date
    December 1, 2008
    Manufacturer
    LEEDS, UK
    Product Code
    FTL
    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: VENTRAL HERNIA REPAIR. ACCORDING TO THE REPORTER: THE A PATIENT DEVELOPED FECULENT DISCHARGE FROM THE INCISION AFTER MULTIPLE VIOLENT COUGHING ATTACKS AT HOME. AFTER FOUR DAYS OF THIS DISCHARGE THE PATIENT CAME INTO THE OFFICE. UPON INSPECTION IN THE OPERATING ROOM THE SURGEON FOUND THAT THE BIOLOGIC IMPLANT HAD SPLIT DOWN THE MIDDLE. UNDERLYING ADHERENT BOWEL HAD SPLIT AS WELL IN TWO SEPARATE PLACES. PATIENT HAS DEVELOPED ANOTHER FISTULA UNRELATED TO THE BIOLOGIC IMPLANT. THERE WAS A REPORTED BOWEL INJURY. THE BIOLOGIC IMPLANT WAS REMOVED AND THE BOWEL WAS REPAIRED WITH A VICRYL MESH IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMACOL 20X30 1.5MM PORCINE DERMAL IMPLANT FTL LEEDS, UK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R