BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 1000432 · Received February 21, 2008

    Report

    Report Number
    2210968-2008-00102
    Event Type
    Injury
    Date Received
    February 21, 2008
    Report Date
    January 22, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A PELVIC FLOOR REPAIR PROCEDURE IN 2007. ON AN UNK DATE POST-OPERATIVELY, THE PT EXPERIENCED BURNING UPON URINATION. THE PT WAS TREATED WITH CIPRO FOR FIVE DAYS FOR INFLAMMATION. NO SYMPTOM IMPROVEMENT OCCURRED AND THE PT WAS TREATED WITH AMOXICILLIN DURING 2008. THE PT ALSO EXPERIENCED POST-OPERATIVE CONSTIPATION WITH NO BOWEL MOVEMENT FOR ONE WEEK. THE PT SAW A PROCOLOGIST WHO SUGGESTED THAT THE PT HAD INFLAMMATION AND THAT THE MESH MAY BE IN A BALL. THE PT WAS PRESCRIBED TREATMENT OF INCREASED FIBER INTAKE. THE PT ALSO SAW AN ALLERGIST WHO ADVISED THAT AN ALLERGY TO THE MESH WAS UNLIKELY. THE PT HAS A FOLLOW-UP OFFICE VISIT WITH THE SURGEON SOON.

    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 71 YR Required Intervention