BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 2924743 · Received January 22, 2013

    Report

    Report Number
    2210968-2013-00505
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    January 6, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT A SYMPTOMATIC CYSTOCELE, A SYMPTOMATIC RECTOCELE, UTERINE PROLAPSE, POOR RECTOVAGINAL FASCIA, POOR PUBOCERVICAL FASCIA, A CYSTOURETHROCELE, AND STRESS URINARY INCONTINENCE ON (B)(6) 2008 AND MESH WAS IMPLANTED. THE PATIENT UNDERWENT THE CONCURRENT PROCEDURE OF CYSTOSCOPY DURING MESH IMPLANTATION. 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. IT WAS NOTED THAT THE PATIENT UNDERWENT A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY, CYSTOSCOPY, BOSTON SCIENTIFIC ADVANTAGE FIT SLING IMPLANTATION, AND EXCISION OF POSTERIOR MESH ARMS ON (B)(6) 2010 DUE TO UTERINE PROLAPSE AND STRESS URINARY INCONTINENCE WITH INTRINSIC SPHINCTER DEFICIENCY WHICH THE PATIENT HAD A HISTORY OF PRIOR TO MESH. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2008 CONCURRENTLY WITH A HYSTERECTOMY. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2013 DUE TO MESH EROSION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY/BOWEL PROBLEMS, ORGAN PERFORATION, FISTULAE, RECURRENCE, BLEEDING, DYSPAREUNIA, NEUROMUSCULAR PROBLEMS AND VAGINAL SCARRING. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF PROSTHETIC VAGINAL GRAFT AND REMOVAL OF REVISION OF SYNTHETIC MESH SLING ON (B)(6) 2013 DUE TO EROSION. (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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2013-00506. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH. 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 GYNECOLOGICAL PROCEDURES ON (B)(6) 2008 AND (B)(6) 2010 AND MESH, PINNACLE PELVIC FLOOR REPAIR KIT AND ADVANTAGE FIT SYSTEM WERE 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
    30471 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3071157

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention