BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT ABBREVO CONTINENCE SYSTEM

    MDR report key: 3202987 · Received July 2, 2013

    Report

    Report Number
    2210968-2013-11984
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    December 13, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K100936
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    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 ON (B)(6) 2012 THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT STRESS URINARY INCONTINENCE AND MESH WAS IMPLANTED ALONG WITH THE CONCURRENT PROCEDURE OF HYSTERECTOMY. IT WAS REPORTED THAT FOLLOWING INSERTION OF THE MESH THE PATIENT EXPERIENCED PAIN, INFECTION, URINARY PROBLEMS, RECURRENCE, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH ROBOTIC TOTAL SUPRACERVICAL HYSTERECTOMY, TENSION FREE VAGINAL TAPING OBTURATOR ABBREVO TECHNIQUE USING A 12 CM POLYPROPYLENE MESH. IT WAS REPORTED THAT THE PRE-OP DIAGNOSIS WERE DYSFUNCTIONAL UTERINE BLEEDING, FIBROID UTERUS, STRESS URINARY INCONTINENCE, AND STATUS POST EXTENSIVE WORKUP FOR SURGICAL APPROACH.

    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 ON (B)(6) 2010 AND MESH WAS IMPLANTED. THE PATIENT 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
    302991 GYNECARE TVT ABBREVO CONTINENCE SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 3571432

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention