BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3162618 · Received June 11, 2013

    Report

    Report Number
    2210968-2013-07002
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 21, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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

    THE PATIENT UNDERWENT MESH IMPLANTATION DUE TO STRESS URINARY INCONTINENCE. THE OUTCOMES ATTRIBUTED TO THE DEVICE ARE PAIN, EROSION, EXTRUSION, RECURRENCE, DYSPAREUNIA AND URINARY PROBLEMS. THE PATIENT UNDERWENT A HYSTERECTOMY ON (B)(6) 2009. IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL ON (B)(6) 2009. (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. IT WAS REPORTED THAT THE PATIENT UNDERWENT BSO, VAGINAL VAULT COLPOSUSPENSION TO THE RIGHT, AND LOWER UTEROSACRAL LIGAMENT AND ENTEROCELE REPAIR ON (B)(6) 2009. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263266 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3222339

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention