BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2945554 · Received February 6, 2013

    Report

    Report Number
    2210968-2013-00842
    Event Type
    Injury
    Date Received
    February 6, 2013
    Report Date
    January 17, 2013
    Manufacturer
    ETHICON , INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 TO TREAT PELVIC ORGAN PROLAPSE, REAL INCONTINENCE AND AN OBTURATOR SLING WAS IMPLANTED. CONCOMITANTLY THE PATIENT UNDERWENT A CYSTOCELE REPAIR, CYSTO, RECTOCELE REPAIR, ANAL SPHINCTEROPLASTY. OUTCOMES REPORTED AS PAIN, INFECTION, URINARY AND BOWEL PROBLEMS, AND RECURRENCE. (B)(4). .

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: 2 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). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED STRESS URINARY INCONTINENCE.

    Additional Manufacturer Narrative · 1

    (B)(4).: IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED VAGINAL ITCHING AND MALODOROUS VAGINAL DISCHARGE.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY FREQUENCY. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2010 BY DR. (B)(6) AT THE (B)(6) CLINIC FOUNDATION.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED BURNING SENSATION AND DISCOMFORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO TREAT STRESS URINARY INCONTINENCE AND A SLING WAS IMPLANTED ON (B)(6) 2007. IT WAS REPORTED THAT SHE EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE, URINARY TRACT INFECTIONS 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
    49708 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON , INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention