BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 1822006 · Received August 25, 2010

    Report

    Report Number
    2210968-2010-00989
    Event Type
    Injury
    Date Received
    August 25, 2010
    Date of Event
    June 28, 2010
    Report Date
    August 16, 2010
    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

    (B)(4) - DYSPAREUNIA - (B)(4) - MESH EXPOSURE: 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 ON AN UNK DATE. IMMEDIATELY AFTER THE PROCEDURE, THE PT HAD ACUTE ABDOMINAL PAIN AND FREE FLUID IN THE ABDOMEN FOR SIX WEEKS. THE DOCTORS ALTERNATED BETWEEN OVARIAN CYST AND DIVERTICULITIS. THEN FOUR AND ONE HALF MONTHS LATER, AFTER FOUR ROUNDS OF ANTIBIOTICS AND REDUCED ACTIVITIES, THE PT WENT TO A GYNECOLOGIST BECAUSE MESH WAS EXPOSED IN THE BOTTOM OF THE VAGINAL OPENING. THE PATIENT ALSO HAD HIP PAIN IMMEDIATELY AFTER SURGERY WITH TROUBLE WALKING WHICH CLEARED UP AFTER THREE MONTHS. AT ELEVEN MONTHS AFTER THE SURGERY, SEVERE HIP PAIN AND PAIN IN LOW BACK OCCURRED AND THE PATIENT WAS DIAGNOSED WITH SACROILITIS. THE PT WAS TREATED WITH ANTIBIOTICS AND PHYSICAL THERAPY. THE PT CONTINUED TO HAVE RECTAL PAIN, PAIN WHEN SITTING, HIP PAIN, ABDOMINAL PAIN, PAIN WITH SEX. THEN FOURTEEN MONTHS AFTER SURGERY, THE PT NOTICED SEVERE ODOR WITH DISCHARGE VAGINALLY FROM THE EXPOSED MESH. A FISTULA HAD FORMED AND AN INFECTION HAD OCCURRED. THE PT UNDERWENT A RE-OPERATION. TWO WEEKS POST-OPERATIVELY, THE PT HAS SOME RECTAL PAIN. NO FURTHER INFO IS AVAILABLE.

    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