BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 1173454 · Received September 23, 2008

    Report

    Report Number
    2210968-2008-00862
    Event Type
    Injury
    Date Received
    September 23, 2008
    Report Date
    August 23, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 09/22/2008. DEVICE ARM TIGHTENED - CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A TOTAL PELVIC FLOOR PROCEDURE IN 2008. AT FOUR WEEKS POST-OPERATIVE, THE PT'S STRESS LEAKAGE WHICH HAD BEEN PRESENT PRE-OPERATIVELY, HAD WORSENED. AT SIX MONTHS POST-OPERATIVE, THE PT COMPLAINED OF RIGHT PELVIC DISCOMFORT DURING INTERCOURSE. ON VAGINAL EXAMINATION, THE SURGEON CAN FEEL A TIGHTENED RIDGE ON THE RIGHT ANTERIOR SEGMENT JUST BEHIND THE PUBIS WHICH IS EXTREMELY TENDER. THE SURGEON OPINES THAT CAUSE OF THE DISCOMFORT IS THAT THE RIGHT ANTERIOR STRAP/ARM OF THE DEVICE MIGHT BE OVER-TENSIONED. THE SURGEON PLANS A PROCEDURE TO DIVIDE THE SUPERFICIAL ARM OF THE RIGHT ANTERIOR STRAP FROM THE BODY TO REDUCE THE TENSION AND ALSO TO PERFORM AN OBTURATOR SLING PROCEDURE FOR THE STRESS INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3069423

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention