BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2875080 · Received December 17, 2012

    Report

    Report Number
    2210968-2012-08143
    Event Type
    Injury
    Date Received
    December 17, 2012
    Report Date
    November 26, 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 CONCURRENTLY WITH HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY DUE TO STRESS URINARY INCONTINENCE AND BLADDER PROLAPSE. IT WAS REPORTED THAT FOLLOWING IMPLANT THE PATIENT EXPERIENCED PAIN, INFECTION, URINARY/BOWEL PROBLEMS, FISTULAE, RECURRENCE, DYSPAREUNIA, NEUROMUSCULAR PROBLEMS AND VAGINAL SCARRING. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY FREQUENCY, URGE INCONTINENCE, AND URINARY TRACT INFECTIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY URGENCY, NOCTURIA AND PELVIC PROLAPSE.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY FREQUENCY, URGE INCONTINENCE, AND URINARY TRACT INFECTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND AN OBTURATOR SLING WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention