BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 1881215 · Received October 20, 2010

    Report

    Report Number
    2210968-2010-01343
    Event Type
    Injury
    Date Received
    October 20, 2010
    Report Date
    September 20, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PAIN OCCURRED. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A POSTERIOR PELVIC FLOOR REPAIR PROCEDURE ON AN UNK DATE. CONCOMITANTLY, A SLING PROCEDURE WAS ALSO PERFORMED. THE PT WENT TO A NEW SURGEON ABOUT ONE MONTH POST-OPERATIVELY WITH SEVERE PAIN OVER THE SACROILIAC JOINT AND BUTTOCK REGION RETROPUBICALLY WITH PAIN RADIATING INTO THE UPPER LIMB. UPON EXAMINATION, THE SURGEON CAN FEEL STIFFENED MESH AND THE VAGINA IS EXTREMELY PAINFUL, MOSTLY TOWARDS THE PELVIC SIDEWALLS. THE PT CAN'T SIT OR PASS A STOOL WITHOUT EXCRUCIATING PAIN. THIS SURGEON OPINES THAT THE OPERATING SURGEON MIGHT HAVE PERFORATED THE NERVE CLOSE TO THE ISCHIAL SPINE WITH THE POSTERIOR TROCAR OF THE POSTERIOR MESH. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention CONCOMITANT TVT-O PROCEDURE ON AN UNK DATE