BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3103000 · Received May 9, 2013

    Report

    Report Number
    2210968-2013-05231
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 18, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    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

    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, LAPAROSCOPIC 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). 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 2210968-2013-05234. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IT WAS REPORTED THAT FOLLOWING INSERTION, THE PATIENT EXPERIENCED CERVICAL PROLAPSE.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT HAD A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT STRESS URINARY INCONTINENCE AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT HAD A CONCURRENT PROCEDURE OF A HYSTERECTOMY PERFORMED DURING MESH IMPLANTATION. IT WAS REPORTED THAT FOLLOWING INSERTION, THE PATIENT EXPERIENCED INFECTIONS, VAGINAL PAIN, URINARY PROBLEMS DYSPAREUNIA, EXTRUSION OF MESH, PELVIC PAIN AND RECURRENCE OF URINARY TRACT INFECTIONS. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    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
    204379 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3372683

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention