BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 3061730 · Received April 16, 2013

    Report

    Report Number
    2210968-2013-03973
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    March 27, 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
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT PELVIC RELAXATION, CYSTOCELE, RECTOCELE, VAULT PROLAPSED, STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT THE PATIENT HAD A CONCURRENT PROCEDURE OF A CYSTOSCOPY PERFORMED DURING MESH IMPLANTATION. IT IS NOTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2008 FOR RECURRENT CYSTOCELE WITH VAGINAL VAULT PROLAPSE AND URINARY RETENTION, AS WELL AS MESH EROSION.(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. 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) 2007 AND MESH AND BOSTON SCIENTIFIC LYNX SUPRAPUBIC MID-URETHRAL SLING SYSTEM WERE 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
    162330 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC OTO ETHICON, INC. NA ZAB240

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention LYNX SUPRAPUBIC MID-URETHRAL