BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PERMACOL PRODUCT

    MDR report key: 4085551 · Received July 9, 2014

    Report

    Report Number
    9617613-2014-00135
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC
    Product Code
    FTL
    PMA / PMN Number
    K992556
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    LITERATURE REVIEW: IN AN ARTICLE ENTITLED "PELVIC FLOOR RECONSTRUCTION WITH A BIOLOGICAL MESH AFTER ELAPE'' WRITTEN BY K.K. JENSEN ET AL PUBLISHED IN COLORECTAL DISEASE 16, 192-197. THERE WERE 53 PATIENTS WHO UNDERWENT EXTRALEVATOR ABDOMINOPERINEAL EXCISION FOR LOW RECTAL CANCER FROM AUGUST 2007 TO AUGUST 2011. THREE PATIENTS DEVELOPED PERINEAL HERNIA. ACCORDING TO THE AUTHORS, "THE THREE HERNIAS FOUND IN OUR STUDY COULD BE A RESULT OF WEAKENING OR DISSOLUTION OF THE MESH, ALTHOUGH NO CONCLUSION CAN BE DRAWN BASED ON OUR DATA. NONE OF THE THREE PATIENTS RECEIVED SURGICAL TREATMENT OF THE HERNIA, SINCE NO COMPLICATIONS TO THE HERNIAS OCCURRED, AND TWO OF THE PATIENTS WERE ASYMPTOMATIC." THERE WAS ALSO A PATIENT WHO HAD A FISTULA AND UNDERWENT EXPLORATION THAT REVEALED A HOLE IN THE MESH. THIS IS FOR ONE OF THE THREE PATIENTS THAT DEVELOPED A PERINEAL HERNIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399158 UNKNOWN PERMACOL PRODUCT UNK FTL COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1