BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 2923912 · Received January 22, 2013

    Report

    Report Number
    2210968-2013-00437
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    January 4, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (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.

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT A CYSTOCELE, A RECTOCELE, AND AN ENTEROCELE. THE PATIENT UNDERWENT SIGMOIDOSCOPY WITH MESH GRAFT EXCISION ON (B)(6) 2008. THE PATIENT UNDERWENT MESH EXCISION AND VAGINAL REPAIR ON (B)(6) 2009, (B)(6) 2009, AND (B)(6) 2010. THE PATIENT UNDERWENT MESH REVISION DUE TO PELVIC PAIN SECONDARY TO MESH REJECTION ON (B)(6) 2012. THE PATIENT UNDERWENT REMOVAL OF SUTURES ON (B)(6) 2012. THE PATIENT UNDERWENT RESECTION OF FOREIGN BODY (MESH) ON (B)(6) 2012 DUE TO MESH EXTRUSION AND PAIN. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT CYSTOCELE, RECTOCELE AND ENTEROCELE. IT WAS REPORTED THAT THE PATIENT UNDERWENT THE CONCURRENT PROCEDURES OF PARAVAGINAL REPAIR WITH MESH GRAFT, RECTOCELE REPAIR WITH GRAFT, VAGINAL VAULT SUSPENSION WITH MESH GRAFT, ENTEROCELE REPAIR WITH MESH GRAFT AND CYSTOSCOPY. IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGID SIGMOIDOSCOPY AND PELVIC EXAM ON (B)(6) 2008 FOR PELVIC PAIN POST RECTOCELE AND CYSTOCELE REPAIR. IT IS REPORTED THAT THE ¿WINGS¿ OF THE MESH WERE REMOVED. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION ON (B)(6) 2009 TO REMOVE EXPOSED MESH. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION ON (B)(6) 2009 FOR MESH EROSION. IT IS REPORTED THAT THIS SURGERY TOOK PLACE IMMEDIATELY FOLLOWING BREAST RECONSTRUCTION SURGERY. IT WAS REPORTED THAT THE PATIENT UNDERWENT VAGINAL MESH EXCISION AND CYSTOSCOPY ON (B)(6) 2010 FOR MESH EXPOSURE.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT RESECTION OF AN ANTERIOR VAGINAL WALL MESH WITH COPIOUS IRRIGATION ON (B)(6) 2014 BY DR. (B)(6), D.O AND (B)(6), D.O DUE TO AN ANTERIOR VAGINAL WALL MESH INFECTION AND EROSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND MESH WAS USED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT RESECTION OF AN ANTERIOR VAGINAL WALL MESH WITH COPIOUS IRRIGATION ON (B)(6) 2014 BY DR. (B)(6), D.O AND (B)(6), D.O DUE TO AN ANTERIOR VAGINAL WALL MESH INFECTION AND EROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29103 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention