BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2971883 · Received February 21, 2013

    Report

    Report Number
    2210968-2013-01336
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    February 1, 2013
    Manufacturer
    ETHICON INC
    Product Code
    OTN
    PMA / PMN Number
    K033568
    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). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND A MESH WAS IMPLANTED DUE TO URINARY AND BLADDER PROBLEMS. THE PATIENT EXPERIENCED PAIN, EROSION, URINARY PROBLEMS, RECURRENCE, DYSPAREUNIA, AND VAGINAL SCARRING. THE PATIENT UNDERWENT EXCISION OF VAGINAL MESH AND CYSTOSCOPY ON (B)(6) 2010 FOR EXTRUDED VAGINAL MESH AND OBSTRUCTIVE VOIDING SYMPTOMS. IT WAS REPORTED THAT THE PATIENT UNDERWENT A CYSTOGRAM ON (B)(6) 2010 FOR STRESS URINARY INCONTINENCE. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH A CYSTOSCOPY DUE TO STRESS URINARY INCONTINENCE. THE PATIENT UNDERWENT A CYSTOSCOPY AND PLACEMENT OF BILATERAL URETERAL STENTS DUE TO PELVIC PAIN ON (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.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL PATIENT CODES: (B)(4) - BLOOD LOSS, (B)(4) - URINARY FREQUENCY, (B)(4) - NOCTURIA ADDITIONAL NARRATIVE: IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED VAGINAL BLEEDING, URINARY FREQUENCY, AND NOCTURIA.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY TRACT INFECTION AND STRESS URINARY INCONTINENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND AN OBTURATOR SLING WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL TISSUES, 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
    75831 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON INC NA 3308215

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention