BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT RETROPUBIC SYSTEM

    MDR report key: 3201369 · Received July 2, 2013

    Report

    Report Number
    2210968-2013-11878
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    September 20, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    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 DUE TO SUI, UTERINE PROLAPSE, CYSTOCELE AND RECTOCELE. IT WAS REPORTED THAT CONCURRENTLY THE PATIENT ALSO HAD ATRIUM PROLITE MESH IMPLANT ON (B)(6) 2003.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH HYSTERECTOMY AND A&P REPAIRS. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED INFECTION, URINARY PROBLEMS, ORGAN PERFORATION, FISTULAE AND VAGINAL SCARRING. IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL OF FOREIGN BODY IN BLADDER ON (B)(6) 2004. IT WAS REPORTED THAT PATIENT UNDERWENT EXCISION OF MESH ON (B)(6) 2004 DUE TO MESH EROSION. IT WAS REPORTED THAT PATIENT UNDERWENT ANOTHER EXCISION OF MESH IN 2008 DUE TO MESH TRAVELED INTO VAGINAL WALL AND BLADDER. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2003 AND 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
    303430 GYNECARE TVT RETROPUBIC SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 1078182

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention ATRIUM PROLITE