BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 3132945 · Received May 29, 2013

    Report

    Report Number
    2210968-2013-05978
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 7, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH CYSTOSCOPY, DUE TO GRADE 3 CYSTOCELE, GRADE 2 RECTOCELE, AND ENTEROCELE . IT WAS NOTED THAT ON (B)(6) 2007 THAT THE PATIENT UNDERWENT A PROCEDURE (URODYNAMIC STUDY) IN WHICH A PESSARY WAS INSERTED DUE TO STRESS URINARY INCONTINENCE, PROLAPSE, AND DETRUSSOR INSTABILITY. IT WAS NOTED THAT ON (B)(6) 2012 THAT THE PATIENT WAS ADMITTED FOR A COLPECTOMY, COLPOCLEISIS, ENTEROCELE REPAIR, PERINEOPLASTY AND CYSTOSCOPY, DUE TO CYSTOCELE AND VAULT PROLAPSE.

    Additional Manufacturer Narrative · 1

    LAWYER-FILED REPORT (B)(6). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT CYSTOCELE, RECTOCELE, VAGINAL VAULT PROLAPSE, ENTEROCELE AND STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, INFECTION, URINARY PROBLEMS AND RECURRENCE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PELVIC PAIN, CONTRACTION OF VAGINAL GRAFT AND UNDERWENT MESH REVISION ON (B)(6) 2008. IT WAS REPORTED THAT THE PATIENT UNDERWENT COLPECTOMY, COLPOCLEISIS, ENTEROCELE REPAIR, CYSTOSCOPY AND PERINEOPLASTY. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-05975. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND MESH WAS IMPLANTED. 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
    236740 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON, INC. NA 3088838

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention