BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 1822836 · Received August 30, 2010

    Report

    Report Number
    2210968-2010-01019
    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 SMALL VAGINAL MESH EROSION AT THE INCISION LINE WHICH RESOLVED AFTER IN-OFFICE TRIMMING AND LOCAL ESTROGEN USE. 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