BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 1033807 · Received April 24, 2008

    Report

    Report Number
    2210968-2008-00272
    Event Type
    Injury
    Date Received
    April 24, 2008
    Report Date
    March 25, 2008
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF TWO MEDWATCHS SUBMITTED FOR THIS DEVICE. SEE ALSO MEDWATCH 2210968-2007-00271. THE SAME DEVICE IS REPRESENTED IN EACH MEDWATCH AS IT WAS INVOLVED IN TWO EVENTS. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANTERIOR AND POSTERIOR PELVIC FLOOR REPAIR PROCEDURE IN 2008. POST-OPERATIVELY, A MESH EROSION OCCURRED AND A PROCEDURE TO TRIM THE MESH IS PLANNED.

    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 Required Intervention