BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 3121499 · Received May 21, 2013

    Report

    Report Number
    2210968-2013-05700
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    May 1, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 UTERINE PROLAPSE, CYSTOCELE, VAGINAL VAULT PROLAPSE, RECTOCELE, STRESS URINARY INCONTINENCE, WEAKENING OF RECTOVAGINAL FASCIA, AND WEAKENING OF PUBOCERVICAL FASCIA AND MESH WAS IMPLANTED. AT THE TIME OF IMPLANTATION THE PATIENT UNDERWENT THE CONCURRENT PROCEDURES OF ANTERIOR AND POSTERIOR COLPORRHAPHY, VAGINAL VAULT SUSPENSION, INSERTION OF MESH ANTERIOR, AND INSERTION OF MESH POSTERIOR.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2007 CONCURRENTLY WITH A TOTAL VAGINAL HYSTERECTOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 THREE MEDWATCHES BEING SUBMITTED AS THREE DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-05701 AND 2210968-2013-05702. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT MESH WAS IMPLANTED ALONG WITH CONCURRENT HYSTERECTOMY DUE TO STRESS URINARY INCONTINENCE AND PELVIC ORGAN PROLAPSED. FOLLOWING INSERTION THE PATIENT EXPERIENCED EROSION, EXTRUSION, URINARY PROBLEMS, RECURRENCE, BLEEDING AND DYSPAREUNIA. NO ADDITIONAL INFORMATION WAS PROVIDED.THIS IS ONE OF THREE MEDWATCHES BEING SUBMITTED AS THREE DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-05701 AND MEDWATCH 2210968-2012-. 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.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2007 DUE TO EROSION. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT SLING REVISION, URETHROLYSIS AND URETHROPLASTY ON (B)(6) 2014 DUE TO URETHRAL STRICTURE AND COMPLICATIONS DUE TO URINARY DEVICE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF 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
    224577 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON, INC. NA 2983810

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention