BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT SECUR SYSTEM

    MDR report key: 3242277 · Received July 23, 2013

    Report

    Report Number
    2210968-2013-14063
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    May 14, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    PAH
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED CONCURRENTLY WITH LAPAROSCOPIC CHOLECYSTECTOMY DUE TO SUI. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED INFECTION, URINARY AND BOWEL PROBLEMS, AND BLEEDING. (B)(4).

    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.

    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). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED FREQUENCY, URGENCY, AND URINARY TRACT INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED INTO THE PATIENT. IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND MESH WAS IMPLANTED INTO THE PATIENT. IT IS REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF INTERNAL TISSUES, AND 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
    342654 GYNECARE TVT SECUR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC PAH ETHICON INC. UNK 2942805

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention