BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 3213036 · Received July 9, 2013

    Report

    Report Number
    2210968-2013-12585
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    June 20, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    UNKNOWN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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

    THIS MEDWATCH REPORT # 2210968-2013-12585 IS BEING VOIDED AS IT IS A DUPLICATE OF MEDWATCH REPORT # 2210968-2013-04392. PLEASE SEE MEDWATCH REPORT # 2210968-2013-04392 FOR ALL INFORMATION REGARDING THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). REASON FOR IMPLANT: SUI, URETOVAGINAL PROLPASE , CYSTOCELE RECTOCELE. CONCURRENT PROCEDURES: TLH/BSO WITH COMPLETE BILATERAL PELVIC AND PERIAORIC LYMPH NODE DISSECTION WITH DA VINCI ROBOT. POSTERIOR COLPRRHAPHY WITH PROLIFT AND M MESH GRAFT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 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
    314345 UNKNOWN MESH, SURGICAL, SYNTHETIC FTL ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention