BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2932766 · Received January 29, 2013

    Report

    Report Number
    2210968-2013-00583
    Event Type
    Injury
    Date Received
    January 29, 2013
    Report Date
    January 11, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: THE PATIENT UNDERWENT MESH IMPLANTATION CONCURRENTLY WITH TRANSABDOMINAL HYSTERECTOMY WITH LEFT SALPINGO-OOPHORECTOMY, LYSIS OF ADHESIONS, POSTERIOR COLPORRHAPHY, AND CYSTOSCOPY DUE TO PELVIC PAIN, DYSMENORRHEAL, DYSPAREUNIA, STRESS URINARY INCONTINENCE, SEVERE PELVIC ADHESIVE DISEASE, AND FIBROIDS. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED EXCRUCIATING PELVIC, BACK AND VAGINAL PAIN, VAGINAL BLEEDING, SEVERE DYSPAREUNIA AND DISCOMFORT. IT WAS REPORTED THAT IN 2007 AND 2009, THE PATIENT UNDERWENT MESH REVISIONS DUE TO PAIN AND DISCOMFORT. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2012 DUE TO PELVIC PAIN, PAINFUL INTERCOURSE, BLEEDING AND URINARY LEAKAGE. IT WAS REPORTED THAT ON (B)(6) 2008: PATIENT UNDERWENT EXPLORATORY LAP, RIGHT SALPHINO-OOPHORECTOMY, LYSIS OF DENSE PELVIC ADHESIONS, REPAIR OF SMALL CYSTOTOMY IN THE DOME OF THE BLADDER. (B)(4) ¿ DYSPAREUNIA; URINARY LEAKAGE.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH TOTAL ABDOMINAL HYSTERECTOMY WITH LEFT SALPINGO-OOPHORECTOMY, LYSES OF ADHESIONS, POSTERIOR COLPORRHAPHY, AND CYSTOSCOPY, DUE TO UTERINE FIBROIDS, IRREGULAR BLEEDING, PELVIC PAIN, DYSPAREUNIA, DYSMENORRHEAL, STRESS URINARY INCONTINENCE AS WELL AS ENTEROCELE AND RECTOCELE. THE PATIENT EXPERIENCED PAIN, URINARY PROBLEMS, BLEEDING, AND DYSPAREUNIA. IT WAS REPORTED THAT THE PATIENT UNDERWENT ATTEMPTED MESH REMOVAL IN (B)(6) 2010. THE PATIENT UNDERWENT PARTIAL MESH REMOVAL ON (B)(6) 2012. IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT OVARY REMOVAL IN (B)(6) 2009.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND MESH WAS USED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39872 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 1225508

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention