BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2861567 · Received December 7, 2012

    Report

    Report Number
    2210968-2012-07966
    Event Type
    Injury
    Date Received
    December 7, 2012
    Report Date
    November 16, 2012
    Manufacturer
    ETHICON INC
    Product Code
    FTL
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND A SLING WAS IMPLANTED. CONCOMITANTLY THE PATIENT UNDERWENT A TRANSVAGINAL HYSTERECTOMY ENTEROCELE AND POSTERIOR REPAIR

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT CYSTOCELE, RECTOCELE, AND ENTEROCELE AND MESH WAS IMPLANTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: IT WAS REPORTED THAT MESH WAS IMPLANTED DUE TO STRESS URINARY INCONTINENCE AND PELVIC ORGAN PROLAPSED. FOLLOWING THE IMPLANTATION THE PATIENT EXPERIENCED PAIN, INFECTION, URINARY PROBLEMS, AND RECURRENCE. THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2012 DUE TO MESH EROSION. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4) ¿ URINARY PROBLEMS; UNDEFINED RECURRENCE.

    Additional Manufacturer Narrative · 1

    (B)(4): NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2004 AND AN OBTURATOR SLING WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. 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 1172187

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention