BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 3111006 · Received May 14, 2013

    Report

    Report Number
    2210968-2013-05469
    Event Type
    Injury
    Date Received
    May 14, 2013
    Report Date
    April 23, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH ANTERIOR AND POSTERIOR COLPORRHAPHY WITH ENTEROCELE REPAIR, AND CYSTOSCOPY, DUE TO STRESS URINARY INCONTINENCE, 4TH DEGREE CYSTOCELE, RECTOCELE, ENTEROCELE, AND 2ND DEGREE UTERINE PROLAPSE, ABSENCE OF PUBOCERVICAL AND RECTOVAGINAL FASCIA. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED SIX MONTHS AFTER SURGERY , PAIN (VAGINAL, PELVIC, RECTAL, LOWER BACK, AND ABDOMINAL), URINARY/BOWEL PROBLEMS, DYSPAREUNIA, DIFFICULTY STANDING, SITTING OR WALKING FOR LONG PERIODS OF TIME, AND DEPRESSION. (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 AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-05471. 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) 2010 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING EROSION, FORMATION OF SCAR TISSUE, ADDITIONAL SURGERIES AND NEUROLOGIC COMPROMISE TO HER STRUCTURES AND TISSUES. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213236 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention