BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 2991588 · Received March 6, 2013

    Report

    Report Number
    2210968-2013-02103
    Event Type
    Injury
    Date Received
    March 6, 2013
    Report Date
    February 11, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 PELVIC RELAXATION WITH RECTOCELE AND CYSTOCELE. THE PATIENT UNDERWENT A CONCURRENT PROCEDURE OF OBTRYX TRANS-OBTURATOR MID-URETHRAL SLING SYSTEM (BOSTON SCIENTIFIC CORP) IMPLANTATION DUE TO STRESS URINARY INCONTINENCE DURING MESH IMPLANTATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE AND SIGNIFICANT SYMPTOMATIC PELVIC FLOOR RELAXATION. IT WAS REPORTED THAT THE PATIENT HAD A CONCURRENT PROCEDURE OF AN ANTERIOR COLPORRHAPHY AND POSTERIOR COLPORRHAPHY PERFORMED DURING MESH IMPLANTATION. IT WAS REPORTED THAT THE PATIENT UNDERWENT URETHROLYSIS AND PLACEMENT OF TRANSOBTURATOR MIDURETERAL SLING ON (B)(6) 2010 DUE TO STRESS URINARY INCONTINENCE AND INCOMPLETE BLADDER EMPTYING. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND MESH AND BOSTON SCIENTIFIC OBTRYX TRANSOBTURATOR 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
    95392 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC OTO ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention OBTRYX TRANSOBTURATOR MID-URETHRAL SLING SYSTEM