BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE MALE SLING SYSTEM

    MDR report key: 2039108 · Received March 25, 2011

    Report

    Report Number
    2183959-2011-00111
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    November 15, 2010
    Report Date
    March 1, 2011
    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

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

    Description of Event or Problem · 1

    (B)(4), SITE #006, SUBJECT #011. ON (B)(6) 2010, AN ADVANCE MALE SLING WAS IMPLANTED. DURING A FOLLOW-UP VISIT ON (B)(6) 2010, IT WAS REPORTED THAT THE PATIENT HAD NUMBNESS ON THE RIGHT SIDE OF HIS SCROTUM, REPORTED AS "RIGHT HEMI. SCROTUM HYPOESTHESIA"; ONSET DATE 11/15/2010. ON 01/25/2011, IT WAS REPORTED THE PATIENT CONTINUES TO HAVE SCROTAL NUMBNESS. NO TREATMENT WAS RECOMMENDED; EVENT STATUS: CONTINUING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S