BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 3093279 · Received May 6, 2013

    Report

    Report Number
    2210968-2013-04964
    Event Type
    Injury
    Date Received
    May 6, 2013
    Report Date
    April 15, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    ATTORNEY

    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). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STAGE 3 PELVIC PROLAPSE. IT WAS REPORTED THAT THE PATIENT HAD THE CONCURRENT PROCEDURES OF A CYSTOSCOPY AND PERINEORRHAPHY PERFORMED DURING MESH IMPLANTATION. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, BLEEDING, INFECTION, URINARY/BOWEL PROBLEMS, DYSPAREUNIA AND VAGINAL SCARRING. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4). 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. THE PATIENT 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
    196366 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC OTO ETHICON, INC. NA UGE941

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention