BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT +M PELVIC FLOOR REPAIR

    MDR report key: 3100435 · Received May 8, 2013

    Report

    Report Number
    2210968-2013-05234
    Event Type
    Injury
    Date Received
    May 8, 2013
    Report Date
    April 18, 2013
    Manufacturer
    ETHICON, INC
    Product Code
    OTP
    PMA / PMN Number
    K071512
    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 MESH EXCISION ON (B)(6) 2014 CONCURRENTLY WITH LAPAROSCOPY WITH LYSIS OF ADHESIONS, VAGINAL ENTEROCELE REPAIR, VAGINAL TRACHELECTOMY; DUE TO EXPOSED MESH, PELVIC PAIN AND CERVICAL PROLAPSE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT PELVIC ORGAN PROLAPSE. IT WAS REPORTED THAT THE PATIENT UNDERWENT THE CONCURRENT PROCEDURE OF A HYSTERECTOMY. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED INFECTIONS, VAGINAL PAIN, URINARY PROBLEMS DYSPAREUNIA, EXTRUSION OF MESH AND PELVIC PAIN, RECURRENCE OF URINARY TRACT INFECTIONS. 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. 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 2210968-2013-05231. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4): THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE AND SYMPTOMATIC PELVIC ORGAN PROLAPSE. IT WAS REPORTED THAT THE PATIENT UNDERWENT THE CONCURRENT PROCEDURES OF SLING IMPLANTATION, URETHROPEXY, SACROSPINOUS SUSPENSION, LAPARASCOPIC SUPRACERVICAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, AND ANTERIOR COLPORRHAPHY DURING MESH IMPLANTATION. POST OPERATIVE REPORT FINDINGS STATE SHE HAD A 6 WEEK SIZE UTERUS THAT WAS BOGGY, SUGGESTIVE OF ADENOMYOSIS, NORMAL SMALL OVARIES. UTERUS PROTRUDED OUT OF THE INTROITUS WITH LARGE ANTERIOR POSTERIOR COMPARTMENT DEFECT AND HYPERMOBILE URETHRA.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED CERVICAL PROLAPSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND MESH AND MESH WERE IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE, URINARY TRACT INFECTIONS 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
    200663 PROLIFT +M PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON, INC NA 3380026

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention