BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL (POLYGLACTIN 910) MESH

    MDR report key: 2832154 · Received November 14, 2012

    Report

    Report Number
    2210968-2012-07253
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 26, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K810428
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    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. THIS IS ONE OF THREE MEDWATCHES BEING SUBMITTED AS THREE DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2012-07251 AND MEDWATCH 2210968-2012-07252. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH PARTIAL VAGINECTOMY AND LEVATOR MYORRHAPHY DUE TO STRESS URINARY INCONTINENCE, TRICOMPARTMENT PROLAPSED AND PELVIC RELAXATION. THE PATIENT UNDERWENT TRANSVAGINAL REVISION/PARTIAL RESECTION OF PROSTHETIC VAGINAL MESH GRAFT ON (B)(6) 2010.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT DUE TO PAIN AND DYPAREUNIA THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2010. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT A SUPRACERVICAL HYSTERECTOMY ON (B)(6) 2011. FOLLOWING PELVIC ORGAN PROLAPSE, AN ENTEROCELE AND FAILED MESH. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4). THIS IS ONE OF THREE MEDWATCHES BEING SUBMITTED AS THREE DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2012-07251 AND MEDWATCH 2210968-2012-07252. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, AND SHE 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
    1 VICRYL (POLYGLACTIN 910) MESH MESH, SURGICAL, ABSORBABLE FTL ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention