BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYS

    MDR report key: 1972229 · Received January 19, 2011

    Report

    Report Number
    2183959-2011-00047
    Event Type
    Injury
    Date Received
    January 19, 2011
    Date of Event
    July 14, 2009
    Report Date
    December 27, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    RELATED TO MFR REPORTS 2183959-2011-00046 AND 2183959-2011-00048. (B)(6); STUDY SUBJECT (B)(6), WAS IMPLANTED ON (B)(6)-2009 WITH AN ELEVATE ANTERIOR. ON (B)(6)-2009, THE PT REPORTED POST OPERATIVE PAIN IN RECTUM, ANUS, BUTTOCK AND PERINEUM. SHE WAS EXAMINED AND TREATED WITH DOXYCYCLINE AND FLAGYL FOR POSSIBLE INFECTION. ON (B)(6)-2009, SHE REPORTED PAIN IN THE TAILBONE AREA AND SHARP SPASMS WITH URINATION, TREATED WITH TOVIAZ. ON (B)(6) 2010, THE PT HAD A FOLLOW-UP VISIT EXAMINATION, THE MESH GRAFT WAS IN PLACE, HOWEVER, THE PTS ANTERIOR VAGINAL MUCOSA WAS DROPPING, CREATING A PSEUDO CYSTOCELE. TREATMENT OR REVISION SURGERY HAS NOT BEEN DETERMINED AT THIS TIME.

    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 Required Intervention APICAL SURGICAL MESH| MONARC SLING| ELEVATE POSTERIOR| ANOPLASTY