BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOURCEMARK INTUBATION STYLET

    MDR report key: 4660810 · Received March 20, 2015

    Report

    Report Number
    3005080538-2013-00002
    Event Type
    Injury
    Date Received
    March 20, 2015
    Date of Event
    September 6, 2013
    Report Date
    May 28, 2014
    Manufacturer
    WELL LEAD MEDICAL CO., LTD.
    Product Code
    BSR
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PLEASE SEE ATTACHED FDA FORM 3500A SENT TO SOURCEMARK, LLC FROM (B)(6) HOSPITAL (B)(6) FOR DESCRIPTION OF EVENT/PROBLEM AS DESCRIBED TO SOURCEMARK, LLC. SOURCEMARK HAS NOT BEEN ABLE TO OBTAIN ANY FURTHER INFORMATION FROM THE HOSPITAL RELATING TO THIS EVENT. UF REF #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191833 SOURCEMARK INTUBATION STYLET INTUBATION STYLET BSR WELL LEAD MEDICAL CO., LTD. M906 20120806

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Required Intervention