BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3110468 · Received May 14, 2013

    Report

    Report Number
    2210968-2013-05460
    Event Type
    Injury
    Date Received
    May 14, 2013
    Report Date
    April 23, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    PAH
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    ADDITIONAL NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2007 DUE TO STRESS URINARY INCONTINENCE AND GRADE I CYSTOSCOPY. THE PATIENT EXPERIENCED PAIN, INFECTION, URINARY PROBLEMS, RECURRENCE, BLEEDING, AND DYSPAREUNIA. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION/REMOVAL. (B)(4) ¿ URINARY PROBLEMS; UNDEFINED RECURRENCE.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT EXTENSIVE ANTERIOR VAGINAL REPAIR WITH GRAFT REINFORCEMENT USING SUSPEND, PUBOVAGINAL SLING WITH SUSPEND, CADAVERIC FASCIA LATA 2 X 12 CM AND CYSTOSCOPY ON (B)(6) 2015 BY (B)(6) DUE TO ANTERIOR VAGINAL COMPARTMENT PROLAPSE AND STRESS URINARY INCONTINENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH 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.

    Description of Event or Problem · 1

    DETAILS: IT WAS REPORTED THAT THE PATIENT UNDERWENT EXTENSIVE ANTERIOR VAGINAL REPAIR WITH GRAFT REINFORCEMENT USING SUSPEND, PUBOVAGINAL SLING WITH SUSPEND, CADAVERIC FASCIA LATA 2 X 12 CM AND CYSTOSCOPY ON (B)(6) 2015 BY (B)(6) DUE TO ANTERIOR VAGINAL COMPARTMENT PROLAPSE AND STRESS URINARY INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212597 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC PAH ETHICON, INC. NA 2984530

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention