BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT RETROPUBIC SYSTEM

    MDR report key: 3180178 · Received June 20, 2013

    Report

    Report Number
    2210968-2013-10642
    Event Type
    Injury
    Date Received
    June 20, 2013
    Report Date
    September 9, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). CONCLUSION: 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). REASON FOR SURGERY: SUI; PELVIC RELAXATION. CONCURRENT PROCEDURES: CYSTOSCOPY. IT WAS REPORTED THAT THE PATIENT UNDERWENT PARTIAL SLING EXCISION & ANTERIOR VAGINAL MESH EXCISION ON (B)(6) 2013 ALONG WITH BIOARC TOT SLING IMPLANTATION AND CYSTOSCOPY, DUE TO RECURRENT SUI, VAGINAL MESH EROSION, COMPLICATIONS OF GU DEVICE AND DYSPAREUNIA. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY/BOWEL PROBLEMS, ORGAN PERFORATION, RECURRENCE, BLEEDING, DYSPAREUNIA, NEUROMUSCULAR PROBLEMS. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2013. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED. IT IS REPORTED THAT THE PATIENT ALSO HAD AMS PRODUCTS IMPLANTED INCLUDING APOGEE AND PERIGEE. NO CLARIFICATION PROVIDED. IT IS FURTHER REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL TISSUES, 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
    280971 GYNECARE TVT RETROPUBIC SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 3036772

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention