BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 728313 · Received June 22, 2006

    Report

    Report Number
    2210968-2006-00440
    Event Type
    Injury
    Date Received
    June 22, 2006
    Report Date
    May 23, 2006
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H6: CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. (510(K)#K013718)

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A PELVIC FLOOR REPAIR. THE SURGEON FELT AT THE TIME OF THE SURGERY THAT ADEQUATE SPACE AT THE APEX WAS MADE FOR THE MESH TO LAY FLAT. HOWEVER, AT THE FOUR WEEK POSTOPERATIVE CHECKUP, THE SURGEON NOTED A BANDING LIDE EFFECT AT THE APEX THAT WAS TENDER TO THE PATIENT UPON PALPATION. THE SURGEON RECOMMENDED MORE TIME BEFORE THE RESUMPTION OF INTERCORSE, HOWEVER THREE WEEKS LATER. THE SURGEON IS PLANNING ON RETURNING THE PATIENT TO SURGERY TO TRANSVERSELY INCISE THE MESH AT THE APEX.

    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 UNKNOWN Hospitalization