BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 3163321 · Received June 11, 2013

    Report

    Report Number
    2210968-2013-10170
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 30, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).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).

    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

    (B)(4). (B)(4) ¿ UNDEFINED RECURRENCE; URINARY/BOWEL PROBLEMS; NEUROMUSCULAR PROBLEMS. ADDITIONAL NARRATIVE: IT WAS REPORTED THAT MESH WAS IMPLANTED DUE TO PELVIC ORGAN PROLAPSED AND STRESS URINARY INCONTINENCE. OUTCOMES ATTRIBUTED TO DEVICE WERE PAIN, EROSION, EXTRUSION, INFECTION, RECURRENCE, BLEEDING, DYSPAREUNIA AND URINARY, BOWEL AND NEUROMUSCULAR PROBLEMS IT WAS REPORTED THAT PATIENT UNDERWENT REVISION ON (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2004 AND MESH AND AMS MONARC WERE IMPLANTED. IT WAS REPORTED THAT SHE 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
    263929 GYNECARE GYNEMESH* PS MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTO ETHICON INC. UNK TGE037

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention AMS MONARC