BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYS.

    MDR report key: 2160803 · Received July 7, 2011

    Report

    Report Number
    2183959-2011-00240
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 15, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT, IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2011 "DIRECTLY" AFTER AN ELEVATE ANTERIOR DEVICE WAS IMPLANTED, THE PATIENT HAD "PAIN IN THE HIP FLEXOR AND BUTT AREA." SHE WAS ALSO UNABLE TO ABDUCT OR ADDUCT HER LEG. THIS DID NOT SUBSIDE OVER THE NEXT SEVERAL DAYS. THE PATIENT WAS REFERRED TO ANOTHER PHYSICIAN WHO DETERMINED SURGERY WAS THE BEST OPTION; THE SURGERY DATE IS UNKNOWN. HE FOUND THE APICAL ARM OF THE MESH TO BE UNDER EXTREME TENSION ON THE RIGHT SIDE AND HE "CUT" IT. SEVERAL CENTIMETERS OF MESH WAS REMOVED FROM THE PATIENT'S RIGHT SIDE. THE PHYSICIAN THOUGHT THAT "IT MAY HAVE BEEN IN THE OBTURATOR CANAL." THE PATIENT WAS "BETTER DIRECTLY AFTER SURGERY AND IS IMPROVING DAILY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYS. SURGICAL MESH FTL AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R GYNECARE TVT-O