BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOS SHIKANI OPTICAL STYLET, PEDIATRIC

    MDR report key: 718246 · Received May 22, 2006

    Report

    Report Number
    2183911-2006-00001
    Event Type
    Other
    Date Received
    May 22, 2006
    Date of Event
    May 11, 2006
    Report Date
    May 19, 2006
    Manufacturer
    CLARUS MEDICAL, LLC.
    Product Code
    HRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN REPORTED DURING INTUBATION OF PT USING THE CLARUS MODEL 30001-10 PEDIATRIC ENDOSCOPE IN CONJUNTION WITH A 4.0MM CUFFED ENDOTRACHEAL TUBE AND OXYGEN A PNEUMOTHORAX CONDITION OCCURED. PHYSICIAN STATED THAT THERE WAS NO PROBLEM WITH THE DEVICE AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOS SHIKANI OPTICAL STYLET, PEDIATRIC ENDOSCOPIC AIRWAY STYLET HRX CLARUS MEDICAL, LLC. 30001-10 *

    Patients

    Seq Age Sex Outcome Treatment
    1 16 MO Required Intervention