BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 1910237 · Received November 22, 2010

    Report

    Report Number
    2210968-2010-01559
    Event Type
    Injury
    Date Received
    November 22, 2010
    Report Date
    October 20, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): MESH EXPOSURE. CONCLUSION: 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 WAS REPORTED THAT IN 2007, A PATIENT UNDERWENT A TOTAL PELVIC FLOOR REPAIR PROCEDURE. SINCE THEN, THE PATIENT HAS HAD MULTIPLE EPISODES OF A PINPOINT EXPOSURE ALONG THE ANTERIOR WALL WHICH DRAINS PURULENT TO OCCASIONALLY BLOOD-TINGED FLUID. THE PATIENT HAS GONE BACK TO THE OPERATING ROOM MULTIPLE TIMES TO OPEN THE AREA, RESECT THE MESH, UNDERMINE THE VAGINAL SKIN, FRESHEN THE EDGES OF THE VAGINAL WOUND, AND CLOSE. IN EACH CASE, THE PINPOINT OPENING WITH DRAINAGE HAS ULTIMATELY RECURRED. THE PATIENT REMAINS SEXUALLY ACTIVE WHEN THE DRAINAGE IS NOT PRESENT. ORAL ANTIBIOTICS AS WELL AS ANTIBIOTIC VAGINAL CREAMS HAVE BEEN ADMINISTERED AT VARIOUS TIMES, THOUGH NONE USED POST-OPERATIVELY. THE PATIENT HAS BACTERIAL VAGINOSIS PROVEN ON CULTURE. SHE IS NOW GOING TO TRY PRE-OPERATIVE AND POST-OPERATIVE ANTIBIOTICS AND ANTIBIOTIC VAGINAL CREAM WITH ANOTHER ATTEMPT AS DESCRIBED ABOVE. THE SURGEON NOW HAS RESECTED APPROXIMATELY FOUR CENTIMETERS OF THE ANTERIOR MESH, SO THE SURGEONS ALSO GOING TO ENTERTAIN PLACEMENT OF A DIFFERENT DEVICE IF SUPPORT OR COVERAGE IS AN ISSUE.

    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 51 YR Required Intervention