BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 3211452 · Received July 8, 2013

    Report

    Report Number
    2210968-2013-12396
    Event Type
    Injury
    Date Received
    July 8, 2013
    Report Date
    November 18, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT MESH WAS IMPLANTED ALONG WITH CONCURRENT LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY, ANTERIOR AND POSTERIOR COLPORRHAPHY WITH GYNEMESH, TENSION FREE VAGINAL TAPE, OBTURATOR PROCEDURE/ TRANSOBTURATOR URETHROPEXY, CYSTOSCOPY AND PERINEORRHAPHY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    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). 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 MESH WAS IMPLANTED ALONG WITH CONCURRENT LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY, ANTERIOR AND POSTERIOR COLPORRHAPHY WITH GYNEMESH, TENSION FREE VAGINAL TAPE, OBTURATURE PROCEDURE/ TRANSOBTURATOR URETHROPEXY, CYSTOSCOPY AND PERINEORRHAPHY.

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT MESH WAS IMPLANTED DUE TO CYSTOCELE, RECTOCELE, UTERINE PROLAPSE, STRESS URINARY INCONTINENCE. FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, BLEEDING, INFECTION, URINARY/BOWEL PROBLEMS, RECURRENCE AND DYSPAREUNIA.IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    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 REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2012 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF INTERNAL TISSUES, AND HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308838 GYNECARE GYNEMESH* PS MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTO ETHICON INC. UNK UJE837

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention