BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 3422593 · Received October 22, 2013

    Report

    Report Number
    2210968-2013-26684
    Event Type
    Injury
    Date Received
    October 22, 2013
    Report Date
    June 8, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND A MESH WAS IMPLANTED CONCURRENTLY WITH ABDOMINAL SACROCOLPOPEXY, ENTEROCELE REPAIR, LAPAROTOMY WITH LYSIS OF ADHESIONS & ENTEROLYSIS, LSO AND URETHROSCOPY DUE TO POP.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    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

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED ATROPHIC VAGINITIS, URINARY TRACT INFECTION, AND URINARY INCONTINENCE.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ALONG WITH CONCURRENT LSO, LYSIS OF ADHESIONS AND ENTEROLYSIS DUE TO POP, RECTOCELE AND ENTEROCELE. IT WAS REPORTED THAT PATIENT UNDERWENT MESH EXTRUSION ON (B)(6) 2014 DUE TO PELVIC PAIN AND DYSPAREUNIA. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REMOVAL, VAGINAL AND SUPRAPUBIC EXPLORATION ON (B)(6) 2014 DUE TO VAGINAL MESH EXTRUSION AND SUPRAPUBIC PAIN AFTER MESH PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND MESH WAS IMPLANTED. IT WAS ALSO REFERENCED THAT THE PATIENT UNDERWENT A PREVIOUS PROCEDURE ON (B)(6) 2005 AND BOSTON SCIENTIFIC REPLIFORM WAS IMPLANTED. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF INTERNAL TISSUES, AND 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
    540659 GYNECARE GYNEMESH* PS MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTO ETHICON INC. UNK UBE327

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention