BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3132086 · Received May 29, 2013

    Report

    Report Number
    2210968-2013-05946
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 7, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K974098
    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): NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT PATIENT CONCURRENTLY UNDERWENT LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY AND LAPAROSCOPIC LEFT SALPINGO-OOPHORECTOMY.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2002 AND MESH WAS IMPLANTED CONCURRENTLY WITH CYSTOCELE AND RECTOCELE DUE TO DYSMENORRHEA, RECTOCELE, CYSTOURETHROCELE, STRESS URINARY INCONTINENCE AND PELVIC ORGAN PROLAPSE. THE PATIENT EXPERIENCED PAIN, INFECTION, URINARY/BOWEL PROBLEMS, BLEEDING AND DYSPAREUNIA. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2002 AND A 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT CONCURRENTLY UNDERWENT LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY AND LAPAROSCOPIC LEFT SALPINGO-OOPHORECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236473 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 925517

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention