BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSIMA PELVIC FLOOR REPAIR KIT

    MDR report key: 2834031 · Received November 15, 2012

    Report

    Report Number
    2210968-2012-07326
    Event Type
    Injury
    Date Received
    November 15, 2012
    Report Date
    October 25, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K063562
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    LAWYER-FILED REPORT (B)(6). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT UTERINE PROLAPSE, A CYSTOCELE AND PELVIC PAIN. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, URINARY/BOWEL PROBLEMS AND DYSPAREUNIA. THE PATIENT UNDERWENT A HYSTERECTOMY IN (B)(6) 2010. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY INCONTINENCE, OVERACTIVE BLADDER, URGENCY, AND FREQUENCY.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT EXCISION OF VAGINAL MESH AND CYSTOSCOPY ON (B)(6) 2012 BY (B)(6) DUE TO PELVIC PAIN FELT SECONDARY TO PREVIOUS VAGINAL MESH IMPLANT.

    Additional Manufacturer Narrative · 1

    IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND MESH WAS USED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSIMA PELVIC FLOOR REPAIR KIT MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3447326

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention