BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 2950255 · Received February 8, 2013

    Report

    Report Number
    2210968-2013-00928
    Event Type
    Injury
    Date Received
    February 8, 2013
    Report Date
    January 15, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT MESH WAS IMPLANTED ALONG WITH CONCURRENT TRANSVAGINAL HYSTERECTOMY AND UTEROSACRAL LIGAMENT PLICATION DUE TO STRESS URINARY INCONTINENCE AND PELVIC ORGAN PROLAPSE. FOLLOWING IMPLANTATION THE PATIENT EXPERIENCED CHRONIC PELVIC AND VAGINAL AREA PAIN AS WELL AS RECURRENT BLADDER INFECTIONS, VAGINAL BLEEDING, VAGINAL INFECTIONS WITH DISCHARGE, EXCRUCIATING PAIN WITH INTERCOURSE AND MESH EROSION REQUIRING ADDITIONAL SURGERY. THE PATIENT UNDERWENT MESH REVISION IN 2008. IT WAS REPORTED THAT PATIENT UNDERWENT RESECTION OF MESH EXTRUSION ON (B)(6) 2007 AND IN (B)(6) 2007. NO ADDITIONAL INFORMATION WAS PROVIDED. (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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 08/23/2016. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION ON (B)(6) 2014 BY DR. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2005 AND MESH AND SPARC WERE IMPLANTED INTO THE PATIENT. IT IS REPORTED THAT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION ON (B)(6) 2014 BY DR. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54707 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC OTO ETHICON, INC. NA TMP034

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention