BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALIGN R IC URETHRAL SUPPORT SYSTEM

    MDR report key: 1111838 · Received August 12, 2008

    Report

    Report Number
    MW5007979
    Event Type
    Malfunction
    Date Received
    August 12, 2008
    Report Date
    August 12, 2008
    Manufacturer
    C.R. BARD
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PRODUCT KIT NOT COMPLETE. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALIGN R IC URETHRAL SUPPORT SYSTEM BLADDER SUSPENSION FTL C.R. BARD BRD1008 HUSB0921

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR