BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 3232526 · Received July 18, 2013

    Report

    Report Number
    2210968-2013-13566
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    September 28, 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

    (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). IT WAS REPORTED THAT MESH WAS IMPLANTED ALONG WITH CONCURRENT HYSTERECTOMY, BILATERAL OOPHORECTOMY AND ENTEROCELE REPAIR DUE TO STRESS URINARY INCONTINENCE, RECTOCELE AND CYSTOCELE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED UTEROVAGINAL PROLAPSE, STRESS INCONTINENCE, ENTEROCELE, CYSTOCELE, WEAKENED PUBOCERVICAL FASCIA, PELVIC ORGAN BULGING OUT OF VAGINA, INCONTINENCE UPON SNEEZING, COUGHING AND LOWER RATE SITTING UP FROM LAYING DOWN, DURING SEX; DISCOMFORT SITTING DUE TO PROLAPSE. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2012 DUE TO MESH HAD ERODED THROUGH THE VAGINAL WALL. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4). 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) 2010 AND MESH WAS IMPLANTED INTO THE PATIENT. IT IS ALSO REPORTED THAT 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
    336117 GYNECARE GYNEMESH* PS MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTO ETHICON INC. BPB640

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention