BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE VIDEO LARYNGSCOPE

    MDR report key: 3221283 · Received May 16, 2013

    Report

    Report Number
    9615393-2013-00150
    Event Type
    Malfunction
    Date Received
    May 16, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    VERATHON MEDICAL (CANADA) ULC.
    Product Code
    BSR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO A MAUDE EVENT REPORT (B)(4), IF THE GLIDERITE RIGID STYLET IS USED DURING INTUBATION WITH THE RECOMMENDED INSERTION TECHNIQUE, THE PT COULD BE PLACED AT RISK FOR INJURY. REVIEW OF LITERATURE SHOWED A NUMBER OF CASES WITH AN INJURY ASSOCIATED WITH THE USE OF THIS PRODUCT AND TECHNIQUE. NO OTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218489 GLIDESCOPE VIDEO LARYNGSCOPE NONE BSR VERATHON MEDICAL (CANADA) ULC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1