BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBURATOR SYSTEM

    MDR report key: 3192924 · Received June 27, 2013

    Report

    Report Number
    2210968-2013-11329
    Event Type
    Injury
    Date Received
    June 27, 2013
    Report Date
    December 1, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISED SLING REPAIR DUE TO MESH REPAIR ON (B)(6) 2007. ON (B)(6) 2009 REVISED VAGINAL GRAFT VIA VAGINA WAS PERFORMED DUE TO MESH REMOVAL. FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY PROBLEMS, DYSPAREUNIA, VAGINAL SCARRING AND ORGAN PERFORATION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE TO STRESS URINARY INCONTINENCE, UTERINE PROLAPSE AND CYSTOCELE.

    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; TOTAL ABDOMINAL HYSTERECTOMY, SALPINGO-OOPHORECTOMY, SACROSPINOUS LIGAMENT SUSPENSION WITH MESH FOR DYSMENORRHEA, FIBROIDS, AND STRESS URINARY INCONTINENCE ON (B)(6) 2006 AND MESH WAS IMPLANTED INTO THE PATIENT. MESH IS MENTIONED ON OPERATIVE SUMMARY. NO CLARIFYING INFORMATION AT THIS TIME. IT IS ALSO REPORTED THAT THE PATIENT IS ALLERGIC TO BAND-AIDS. IT IS FURTHER REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF INTERNAL TISSUES, AND HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292262 GYNECARE TVT OBURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 2917078

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention