BEUDAMED
    FDA Adverse Event Summary report: N

    GLIDERITE RIGID STYLET

    MDR report key: 3050230 · Received April 4, 2013

    Report

    Report Number
    MW5029676
    Date Received
    April 4, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    VERATHON MEDICAL
    Product Code
    BSR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING INTUBATION WHILE USING A GLIDERITE RIGID STYLET COUPLED WITH RECOMMENDED INSERTION TECHNIQUE, PUTS PATIENTS AT RISK FOR SUCH INJURY. LITERATURE REVIEW SHOWED RECENTLY A NUMBER OF CASES WITH SIMILAR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139362 GLIDERITE RIGID STYLET RIGIT STYLET BSR VERATHON MEDICAL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 GLIDESCOPE VIDEO LARYNGOSCOPE