BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 2903635 · Received January 9, 2013

    Report

    Report Number
    2210968-2013-00183
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    December 15, 2012
    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 THE PATIENT UNDERWENT MESH IMPLANTATION TO TREAT PELVIC ORGAN PROLAPSE CONCURRENTLY WITH A TOTAL VAGINAL HYSTERECTOMY, PERINEOPLASTY AND ENTEROCELE REPAIR.

    Additional Manufacturer Narrative · 1

    (B)(4): THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT UTEROVAGINAL PROLAPSE, A GRADE 2 CYSTOCELE, A GRADE 2 RECTOCELE, AND APICAL PROLAPSE PAST THE ISCHIAL SPINE. THE PATIENT UNDERWENT THE CONCURRENT PROCEDURES OF SUSPENSION, CYSTOSCOPY AND PERINEOPLASTY DURING MESH IMPLANTATION. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY PROBLEMS AND DYSPAREUNIA. IT WAS REPORTED THAT THE PATIENT UNDERWENT PARTIAL MESH EXCISION AND REVISION ON (B)(6) 2007 DUE TO EXPOSED MESH AND PAINFUL INTERCOURSE. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND A MESH WAS IMPLANTED. CONCOMITANTLY THE PATIENT UNDERWENT A TOTAL VAGINAL HYSTERECTOMY, PERINEOPLASTY, AND ENTEROCELE REPAIR.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PATIENT CODES: (B)(4) - URINARY FREQUENCY, (B)(4)- URGENCY, (B)(4)- NOCTURIA, RECURRENCE, POST-VOID DRIBBLING, VAGINAL DRYNESS ADDITIONAL NARRATIVE: IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY FREQUENCY, NOCTURIA, RECURRENCE, URGENCY, POST-VOID DRIBBLING, AND VAGINAL DRYNESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007, (PER COMPLAINT) [(B)(6) 2007, PER OPERATIVE REPORT] 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
    11711 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC FTL ETHICON. INC. NA 2919649

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention