BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCANLAN VASCULAR TUNNELER SHEATH

    MDR report key: 3185328 · Received June 18, 2013

    Report

    Report Number
    2126670-2013-00002
    Event Type
    Malfunction
    Date Received
    June 18, 2013
    Date of Event
    May 22, 2013
    Report Date
    June 18, 2013
    Manufacturer
    SCANLAN INTERNATIONAL, INC.
    Product Code
    DWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    SCANLAN INTERNATIONAL, INC. HAS MADE MULTIPLE ATTEMPTS TO GAIN FURTHER INFORMATION. NO FURTHER INFORMATION IS AVAILABLE. DEVICE DISPOSITION UNK.

    Description of Event or Problem · 1

    TIP CAME OFF OF TUNNELER SHEATH DURING PROCEDURE. AS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277538 SCANLAN VASCULAR TUNNELER SHEATH VASCULAR TUNNELER SHEATH DWS SCANLAN INTERNATIONAL, INC. 9009-18 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention