BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 1822858 · Received August 30, 2010

    Report

    Report Number
    2210968-2010-01018
    Event Type
    Injury
    Date Received
    August 30, 2010
    Report Date
    August 5, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MESH EXPOSURE. 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 IS REPORTED THAT A PATIENT UNDERWENT A VAGINAL COLPOPEXY REPAIR PROCEDURE WITH MESH ON A UNKNOWN DATE. THE PATIENT EXPERIENCED A VAGINAL MESH EROSION LOCATED ALONG THE INCISION LINE AND REQUIRED AN ADDITIONAL PROCEDURE IN THE OPERATING ROOM TO REMOVE THE 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 UNK Required Intervention