BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MACROPLASTIQUE

    MDR report key: 3329758 · Received September 3, 2013

    Report

    Report Number
    MW5031697
    Event Type
    Injury
    Date Received
    September 3, 2013
    Date of Event
    August 7, 2013
    Report Date
    September 3, 2013
    Manufacturer
    UROPLASTY, INC
    Product Code
    LNM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MACROPLASTIQUE IMPLANTATION FOR MALE URINARY INCONTINENCE CAUSED A SEVERE WORSENING OF THE INCONTINENCE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436550 MACROPLASTIQUE MACROPLASTIQUE LNM UROPLASTY, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other