BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE MALE SLING SYSTEM

    MDR report key: 1780964 · Received July 27, 2010

    Report

    Report Number
    2183959-2010-00317
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    May 28, 2010
    Report Date
    July 14, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FREQUENCY OF OCCURRENCE OF THE EVENT IS ADDRESSED IN THE DEVICE LABELING. THE FREQUENCY FOR THIS EVENT IS NOT GREATER THAN IS USUAL. NO DEVICE MALFUNCTION WAS REPORTED. SERIAL NUMBER HISTORY REVIEW, DID NOT FIND ANY SIMILAR EVENTS.

    Description of Event or Problem · 1

    SUBJECT WAS IMPLANTED WITH ADVANCE ON (B)(6)2010. ON (B)(6)2010, THE PHYSICIAN REPORTED INFECTION - INCISION SITE WITH FEVER AND PERINEAL PAINS. ON (B)(6)2010, AGGRAVATION OF THE SITE. INFECTION WAS REPORTED WITH INPATIENT COLLECTION OF PUS. PT WAS HOSPITALIZED ON (B)(6)2010 FOR DRAINAGE OF THE ABSCESS, CLINICAL AND BIOCHEMICAL ASSESSMENT. ON (B)(6)2010, IDENTIFICATION OF INFECTIOUS AGENTS: ENTEROCOCCUS FAECALIS AND KLEBSIELLA PNEUMONIAE. APYREXIA AND CICATRIZATION COMPLETED LOCALLY TREATMENT WITH ANTIBIOTICS. ON (B)(6)2010, PT STILL HEALING WITH ANTIBIOTICS. MEDICATION INTERVENTION: BACTRIM TREATMENT CONTINUES, ANTIBIOTICS, CLOSE FOLLOW UP AND MRI ASSESSMENT. PT HAS A FOLLOW UP VISIT IN 3 WEEKS. THE PHYSICIAN REPORTED THE EVENT IS RELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCE MALE SLING SYSTEM SURGICAL MESH FTL AMERICAN MEDICAL SYSTEMS, INC. 72404224

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| R