BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2853370 · Received November 30, 2012

    Report

    Report Number
    2210968-2012-07788
    Event Type
    Injury
    Date Received
    November 30, 2012
    Report Date
    November 14, 2012
    Manufacturer
    ETHICON INC
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE TO TREAT STRESS URINARY INCONTINENCE, MENORRHAGIA, DYSPAREUNIA, DYSMENORRHAGIA, PELVIC PAIN AND AN OBTURATOR SLING WAS IMPLANTED. CONCOMITANTLY THE PATIENT UNDERWENT A LAPAROSCOPIC TOTAL HYSTERECTOMY

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT SCOPE IMPLANT CONCURRENTLY WITH PARTIAL MESH REMOVAL IN (B)(6) 2011. THE PATIENT UNDERWENT MESH REMOVAL IN (B)(6) 2012 DUE TO EROSION, EXTRUSION, URINARY PROBLEMS, BLEEDING, DYSPAREUNIA, AND VAGINAL SCARRING. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED BLADDER INFECTIONS AND URINARY INCONTINENCE.

    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

    (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 THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND A 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED BLADDER INFECTIONS AND URINARY INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON INC NA 3398078

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention