BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 1911358 · Received November 24, 2010

    Report

    Report Number
    2210968-2010-01578
    Event Type
    Injury
    Date Received
    November 24, 2010
    Report Date
    November 2, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    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.

    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

    ADDITIONAL CONTACT NAME: (B)(4), MD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A SURGICAL PROCEDURE TO TREAT STRESS URINARY INCONTINENCE ON (B)(6) 2007 AND AN OBTURATOR SLING WAS IMPLANTED. THE PT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. THE PT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE TO PELVIC PAIN AND URINARY URGENCY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE MESH WAS SURGICALLY REMOVED ON (B)(6) 2009 DUE TO EROSION, PAIN AND DYSPAREUNIA.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED CONCURRENTLY WITH MORENA IUD INSERTION AND CYSTOSCOPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT UNDERWENT VAGINAL HYSTERECTOMY, HIGH UTEROSACRAL VAULT SUSPENSION AND CYSTOSCOPY ON (B)(6) 2008 DUE TO SECOND DEGREE UTERINE PROLAPSE AND PELVIC PAIN. IT WAS REPORTED THAT THE PATIENT UNDERWENT VAGINAL EXCISION OF LESION WITH LACERATION SUTURE ON (B)(6) 2009 DUE TO FOREIGN BODY IN VAGINA AND PELVIC PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 2997024

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention