BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 3182591 · Received June 21, 2013

    Report

    Report Number
    2210968-2013-10752
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    September 26, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 DUE TO POP, VAGINAL PROLAPSE AND MESH WAS IMPLANTED. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY/BOWEL PROBLEMS, ORGAN PERFORATION, FISTULAE AND RECURRENCE. IT WAS REPORTED THAT PATIENT UNDERWENT PARTIAL VAGINECTOMY, RECTAL RESECTION, LAPAROTOMY, LOOP ILEOSTOMY AND MESH REMOVAL ON (B)(6) 2007 DUE TO RECTOVAGINAL FISTULA COMPLICATED BY SACROCOLPOPEXY WITH SYNTHETIC MESH INFECTION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT PATIENT UNDERWENT ON (B)(6) 2008 CLOSURE OF LOOP ILEOSTOMY DUE TO LOOP ILEOSTOMY AND ON (B)(6) 2009 LASER VAPORIZATION OF VULVAR DYSPLASIA DUE TO STAGE 1 SQUAMOUS CARCINOMA OF THE VULVA AND RECURRENT VULVAR INTRAEPITHELIAL NEOPLASIA

    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

    (B)(4). CONCLUSION: 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

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED VULVAR ITCHING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND MESH WAS IMPLANTED. THE PATIENT WAS 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
    282844 GYNECARE GYNEMESH* PS MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTO ETHICON INC. UNK TLP168

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention