BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2945461 · Received February 6, 2013

    Report

    Report Number
    2210968-2013-00813
    Event Type
    Injury
    Date Received
    February 6, 2013
    Report Date
    January 15, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    PAH
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT MESH IMPLANTATION CONCURRENTLY WITH HYSTERECTOMY ON (B)(6) 2011 DUE TO STRESS URINARY INCONTINENCE AND PELVIC ORGAN PROLAPSE, CYSTOCELE, AND RECTOCELE. THE PATIENT THEN EXPERIENCED PAIN, DYSPAREUNIA, AND RECURRENCE. IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL OF EXPOSED MESH ON (B)(6) 2012. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT HARVEST OF RECTUS FASCIA, VAGINAL URETHROLYSIS WITH REMOVAL OF PREVIOUSLY IMPLANTED SLING, PLACEMENT OF RECTUS FASCIA PUBOVAGINAL SLING, EXCISION OF PREVIOUSLY PLACED MESH, VAGINAL PARAVAGINAL REPAIR WITH MIDLINE CYSTOCELE PLACATION AND POSTERIOR REPAIR WITH EXTENSIVE PERINEOPLASTY ON (B)(6) 2012.

    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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-00812. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT 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
    51098 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC PAH ETHICON, INC. NA 3396659

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention