BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH

    MDR report key: 3181923 · Received June 21, 2013

    Report

    Report Number
    2210968-2013-07491
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    May 28, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K001122
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED (B)(6) 2005 IN ORDER TO TREAT GRADE 2-3 CYSTOCELE AND VAGINAL CUFF PROLAPSE CONCURRENTLY WITH POSTERIOR IVS TUNNELER, VAGINAL CUFF SUSPENSION, AND A CYSTOSCOPY. IT WAS REPORTED THAT THE PATIENT UNDERWENT A HYSTERECTOMY AND PUBOVAGINAL SLING IN AUGUST 2004. DUE TO RECURRENT STRESS INCONTINENCE THE PATIENT UNDERWENT PUBOVAGINAL SLING IMPLANTATION WITH BOSTON SCIENTIFIC ADVANTAGE ON (B)(6) 2007. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED RECURRENT CYSTOCELE, RECTOCELE AND ENTEROCELE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND A MESH WAS IMPLANTED. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2007 AND ADVANTAGE POLYPROPYLENE MESH BY BOSTON SCIENTIFIC WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE AND HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283143 PROLENE POLYPROPYLENE MESH MESH FTL ETHICON, INC. NA UGE298

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention