BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2972925 · Received February 21, 2013

    Report

    Report Number
    2210968-2013-01595
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 28, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE. THE PATIENT UNDERWENT THE CONCURRENT PROCEDURE OF A HYSTERECTOMY DURING MESH IMPLANTATION. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, URINARY PROBLEMS AND DYSPAREUNIA. IT WAS REPORTED THAT THE PATIENT UNDERWENT EXCISION OF VAGINAL SCAR TISSUE, ROBOTIC ASSISTED LEFT SALPINGO-OOPHORECTOMY, LYSIS OF ADHESION, FULGURATION OF ENDOMETRIOSIS, AND CYSTOSCOPY WITH HYDRODISTENSION ON (B)(6) 2012 DUE TO SCAR TISSUE IN THE SUBURETHRAL AREA. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT EXCISION OF EXPOSED VAGINAL MESH DUE TO EXPOSURE OF IMPLANTED VAGINAL MESH AND OTHER PROSTHETIC MATERIALS. (B)(4) -URINARY PROBLEMS; DYSPAREUNIA; ENDOMETRIOSIS; MESH EXPOSURE.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE AND A MESH WAS IMPLANTED CONCURRENTLY WITH BILATERAL SALPINGO-OOPHORECTOMY AND RIGHT OOPHORECTOMY.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED RECURRENT URINARY INCONTINENCE AND URINARY RETENTION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PATIENT CODES: (B)(4) - URGENCY, (B)(4) - URINARY FREQUENCY, (B)(4) - BLADDER SYNDROME ADDITIONAL NARRATIVE: IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URGENCY AND URINARY FREQUENCY. IT WAS REPORTED THAT PATIENT UNDERWENT LAPAROSCOPIC LYSIS OF ADHESIONS, DIAGNOSTIC LAPAROSCOPY, LAPAROSCOPY VAGINAL VAULT SUSPENSION, LAPAROSCOPIC APPENDECTOMY, AND BLADDER INSTALLATION ON (B)(6)2013 BY(B)(6) AT (B)(6) DUE TO CHRONIC PELVIC PAIN AND PAINFUL BLADDER SYNDROME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 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. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77210 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3537413

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention