BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS ADVANCE MALE SLING SYSTEM

    MDR report key: 4020035 · Received August 19, 2014

    Report

    Report Number
    2183959-2014-00369
    Event Type
    Injury
    Date Received
    August 19, 2014
    Report Date
    July 22, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    OTM
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH AN ADVANCE URINARY INCONTINENCE SLING DEVICE. AFTER IMPLANTATION THE INCONTINENCE STATUS OF THE PATIENT WAS REPORTEDLY WORSE. SUBSEQUENTLY ON (B)(6) 2014 PATIENT WAS IMPLANTED WITH AN ALTERNATIVE CONTINENCE DEVICE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497365 AMS ADVANCE MALE SLING SYSTEM SURGICAL MESH OTM AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R