BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 1033806 · Received April 24, 2008

    Report

    Report Number
    2210968-2008-00271
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    January 23, 2008
    Report Date
    March 25, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF TWO MEDWATCHS SUBMITTED FOR THIS DEVICE. SEE ALSO MEDWATCH 2210968-2007-00272. THE SAME DEVICE IS REPRESENTED IN EACH MEDWATCH AS IT WAS INVOLVED IN TWO EVENTS. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANTERIOR AND POSTERIOR PELVIC FLOOR REPAIR PROCEDURE IN EARLY 2008. IT WAS REPORTED THAT DURING THE PROCEDURE, THE SURGEON HIT THE ILIAC ARTERY AND THE PATIENT HAD SIGNIFICANT BLEEDING. POST-OPERATIVELY, AN INTERNAL BILATERAL ILIAC ARTERY LIGATION WAS PERFORMED. THE PATIENT WAS GIVEN SIX UNITS OF BLOOD AND ONE UNIT OF PLATELETS. THE SOURCE OF THE BLEEDING WAS UNIDENTIFIABLE; HOWEVER, THE SURGEON OPINES THAT THE INJURY WAS PROBABLY CAUSED BY THE CANNULA GUIDE WITH THE CANNULA DURING ONE OF THE FOUR PASSES FOR THE ANTERIOR REPAIR. THE PATIENT STAYED IN THE CORONARY CARE UNIT FOR FORTY-EIGHT HOURS. THE PATIENT IS NOW DOING FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R