BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2946120 · Received February 6, 2013

    Report

    Report Number
    2210968-2013-00887
    Event Type
    Injury
    Date Received
    February 6, 2013
    Report Date
    January 14, 2013
    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

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH CYSTOSCOPY, DILATION AND CURETTAGE, LAPAROSCOPY, BILATERAL SALPINGO-OOPHORECTOMY, AND LAP GASTRIC BANDING DUE TO SYMPTOMATIC POLYCYSTIC OVARIAN SYNDROME WITH HIRSUTISM, POSTMENOPAUSAL BLEEDING AND STRESS URINARY INCONTINENCE.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2007 BY DR. (B)(6) DUE TO BLADDER OUTLET OBSTRUCTION. IT WAS REPORTED THAT PATIENT UNDERWENT TRANSURETHRAL INJECTION OF COAPTITE ON (B)(6) 2013 BY DR. (B)(6) DUE TO INCONTINENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2006 AND A SLING WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE 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
    49605 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 2917078

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention