BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2113060 · Received June 3, 2011

    Report

    Report Number
    2210968-2011-00697
    Event Type
    Injury
    Date Received
    June 3, 2011
    Report Date
    May 10, 2011
    Manufacturer
    ETHICON
    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

    (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY, BILATERAL SALPINGOOOPHORECTOMY, ENTEROCELE VAGINAL APPROACH, POSTERIOR COLPORRHAPHY, TRANSOBTURATOR TAPE, RIGHT PARTIAL LOBECTOMY AND PERINEORRHAPHY AND SURGICAL PROCEDURE TO TREAT STRESS URINARY INCONTINENCE ON (B)(6) 2009 AND A SLING WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. SHE WAS TREATED FOR VAGINAL BLEEDING ON (B)(6) 2009. SHE WAS RETURNED TO OR ON (B)(6) 2009 FOR A VAGINAL LACERATION REPAIR AND XEROFORM PACKING WAS PLACED. SHE UNDERWENT A MESH REVISION PROCEDURE ON (B)(6) 2009 FOR MESH EROSION IN THE MIDURETHRAL AREA. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2009 CONCURRENTLY WITH A LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY, ENTEROCELE REPAIR, POSTERIOR COLPORRHAPHY, PERINEORRHAPHY, AND RIGHT PARTIAL VULVECTOMY. IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR OF VAGINAL LACERATION ON (B)(6) 2009. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND MESH WAS IMPLANTED CONCURRENTLY WITH A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY, BILATERAL SALPINGOOOPHORECTOMY, ENTEROCELE VAGINAL APPROACH, POSTERIOR COLPORRHAPHY, TRANSOBTURATOR TAPE, RIGHT PARTIAL LOBECTOMY AND PERINEORRHAPHY DUE TO POP, SUI, AND MENORRHAGIA. IT WAS REPORTED THAT FOLLOWING INSERTION, THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS ALSO REPORTED THAT THE PATIENT WAS TREATED FOR VAGINAL BLEEDING ON (B)(6) 2009 AND UNDERWENT A VAGINAL LACERATION REPAIR AND XEROFORM PACKING PLACEMENT ON (B)(6) 2009. THE PATIENT UNDERWENT MESH REVISION ON (B)(6) 2009 FOR MESH EROSION IN THE MIDURETHRAL AREA AND MESH REMOVAL ON (B)(6) 2012 DUE TO VOIDING DYSFUNCTION, SLING EXPOSURE AND INTERSTITIAL CYSTITIS. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SLING PROCEDURE TO TREAT STRESS URINARY INCONTINENCE ON (B)(6) 2009. THE PATIENT EXPERIENCED PAIN, EROSION OF HER 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON NA 3216037

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention