BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 3022393 · Received March 27, 2013

    Report

    Report Number
    2210968-2013-02994
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    March 6, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT PELVIC ORGAN PROLAPSE. IT WAS REPORTED THAT THE PATIENT HAD THE FOLLOWING CONCURRENT PROCEDURES: POSTERIOR REPAIR, REPAIR OF ENTEROCELE, AND PERINEORRHAPHY PERFORMED DURING MESH IMPLANTATION. IT WAS REPORTED THAT PATIENT UNDERWENT THE FOLLOWING PROCEDURES: IN (B)(6) 2010 THE PATIENT UNDERWENT IN OFFICE TRIMMING. ON (B)(6) 2010 THE PATIENT UNDERWENT REVISION/REMOVAL.

    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

    ADDITIONAL INFORMATION. PATIENT CODES: (B)(4) - VAGINISMUS ADDITIONAL NARRATIVE: IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED DYSPAREUNIA AND VAGINISMUS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 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
    126531 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention