BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 3252933 · Received July 29, 2013

    Report

    Report Number
    2210968-2013-14980
    Event Type
    Injury
    Date Received
    July 29, 2013
    Report Date
    September 15, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

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

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT UTEROVAGINAL PROLAPSE, CYSTOCELE, RECTOCELE, AND STRESS URINARY INCONTINENCE AND MESH WAS IMPLANTED ALONG WITH THE CONCURRENT PROCEDURE OF PARTIAL HYSTERECTOMY. IT WAS REPORTED THAT THE FOLLOWING INSERTION OF THE MESH THE PATIENT EXPERIENCED PAIN, INFECTIONS, DYSPAREUNIA, WEIGHT GAIN, HERNIAS DUE TO BLADDER SLING, INABILITY TO WALK OR EXERCISE AND EMOTIONAL STRESS/ANXIETY. IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR REPAIR AND PERINEORRHAPHY, RETROPUBIC SLING ADVANTAGE AND CYSTOSCOPY LEFT ILIOHYPOGASTRIC NERVE RESECTION, CLOSURE OF EXTERNAL OBLIQUE FASCIA DEFECT ON 09/08/2010. IT WAS REPORTED THAT THE PATIENT UNDERWENT OPEN LEFT SPIGELIAN HERNIA REPAIR WITH MESH, LEFT MAJOR PERIPHERAL NERVE TRANSACTION, ILIOHYPOGASTRIC NERVE, IMPLANTATION OF NERVE INTO INTERNAL OBLIQUE MUSCLE ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT WAS IN THE EMERGENCY ROOM DUE TO BLADDER PAIN, LEFT SIDED IN (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND MESH AND ADVANTAGE WERE 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. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352210 GYNECARE GYNEMESH* PS MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTO ETHICON INC. UNK UGR029

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention