BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR

    MDR report key: 2181311 · Received July 21, 2011

    Report

    Report Number
    2183959-2011-00267
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 DURING AN ELEVATE ANTERIOR PROCEDURE ON (B)(6) 2011, THE FIXATING ARM PERFORATED THE RECTUM ON THE PATIENT'S RIGHT SIDE. THE FIXATING ARM WAS REMOVED FROM THE RECTUM. A COLORECTAL SURGEON WAS CONSULTED. THE DEVICE WAS IMPLANTED WITH ANTERIOR FIXATION, BUT NOT POSTERIOR FIXATION. THE PATIENT IS REPORTED TO BE DOING WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R