BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT SECUR SYSTEM

    MDR report key: 3532990 · Received December 23, 2013

    Report

    Report Number
    2210968-2013-33125
    Event Type
    Injury
    Date Received
    December 23, 2013
    Report Date
    January 6, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    PAH
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION OR TAKEDOWN OF PREVIOUS SLING SYNTHETIC SLING, VAGINAL URETHROLYSIS, URETHROCELE REPAIR AND SKIN TISSUE REARRANGEMENT WITH VAGINAL ADVANCEMENT ON (B)(6) 2014 DUE TO GU GRAFT MALFUNCTION, DYSPAREUNIA, BLADDER DYSFUNCTION AND URETHROCELE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007, AND A MESH WAS IMPLANTED, CONCURRENTLY WITH A HYSTERECTOMY, BSO, LYSIS OF ADHESIONS, PLACEMENT OF ON-Q. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION, INFECTION, URINARY PROBLEMS, BOWEL PROBLEMS, RECURRENCE, BLEEDING, DYSPAREUNIA, AND VAGINAL SCARRING. IT WAS REPORTED THAT PATIENT UNDERWENT MESH EXCISION OF VAGINAL HYPERTROPHY, AND CLOSURE OF MESH EXPOSURE ON (B)(6) 2011. NO ADDITIONAL INFORMATION WAS PROVIDED. 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 BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND A MESH 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
    671534 GYNECARE TVT SECUR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC PAH ETHICON INC. UNK 3051645

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention