BEUDAMED
    FDA Adverse Event Other Summary report: N

    PELVICOL

    MDR report key: 614809 · Received July 23, 2004

    Report

    Report Number
    9617613-2004-00005
    Event Type
    Other
    Date Received
    July 23, 2004
    Report Date
    July 21, 2004
    Manufacturer
    TISSUE SCIENCE LABORATORIES, PLC
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR CARRIED OUT A SACROLCPOPEXY PROCEDURE. A COUPLE OF MONTHS POST OPERATIVELY, PT RETURNED COMPLAINING THAT THE PROCEDURE HAD FAILED . WHEN THE DOCTOR LOOKED INTO THIS , SHE FOUND THAT THE PELVICOL HAD TORN IN THE MIDDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PELVICOL PORCINE DERMAL IMPLANT FTL TISSUE SCIENCE LABORATORIES, PLC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other