BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2831514 · Received November 14, 2012

    Report

    Report Number
    2210968-2012-07148
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 23, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE PATIENT UNDERWENT MESH IMPLANTATION DUE TO STRESS URINARY INCONTINENCE WITH CONCURRENT PROCEDURE OF HYSTERECTOMY. AFTER IMPLANTATION, THE PATIENT EXPERIENCED PAIN, INFECTION, RECURRENCE, DYSPAREUNIA, VAGINAL SCARRING, AND NEUROMUSCULAR, URINARY AND BOWEL PROBLEMS. IT WAS REPORTED THAT DUE TO SEVERE PAIN AND INABILITY TO VOID, PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2011. (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 AND MESH WAS IMPLANTED ON (B)(6) 2009 IN ORDER TO TREAT MENOMETRORRHAGIA, ADENOMYOSIS, AND FIBROIDS CONCURRENTLY WITH A BILATERAL SALPINGECTOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY FREQUENCY.

    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

    ADDITIONAL PATIENT CODES: (B)(4)- SPASM, (B)(4)- URINARY TRACT INFECTION, (B)(4)- VAGINAL ATROPHY ADDITIONAL NARRATIVE: IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED VAGINAL ATROPHY, SPASM AND ACUTE URINARY TRACT INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE 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. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3323215

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention