BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM

    MDR report key: 2004040 · Received February 23, 2011

    Report

    Report Number
    2183959-2011-00077
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    October 18, 2010
    Report Date
    February 9, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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

    ON (B)(6) 2010, AN ELEVATE-A WAS IMPLANTED. RECENTLY THE PATIENT DEVELOPED INCREASED PELVIC PAIN TREATED WITH DILAUDID (NARCOTIC). THE PATIENT ALSO HAS REPORTED "OBTURATOR INFLAMMATION" AND PELVIC ABSCESS TREATED WITH CT GUIDED PLACEMENT OF PELVIC DRAINS. AN INFECTION IN HER RIGHT ANKLE HAS BEEN REPORTED AND WAS TREATED WITH MULTIPLE SURGERIES WITH DRAINS. CURRENTLY, THE PATIENT IS BEING TREATED BY INFECTIOUS DISEASE AND ORTHOPEDIC PHYSICIANS EVALUATING HER FOR OSTEOMYELITIS IN THE PELVIC BONE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| O| R