BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNDT EXTERNAL CAROTID SHUNT

    MDR report key: 378635 · Received February 25, 2002

    Report

    Report Number
    2648988-2002-00003
    Event Type
    Malfunction
    Date Received
    February 25, 2002
    Report Date
    February 22, 2002
    Manufacturer
    HEYER-SCHULTE NEUROCARE, INC.
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTS THE SHUNT HAD A HOLE IN IT. THE SHUNT WAS PLACED IN THE PATIENT AND THE PHYSICIAN DISCOVERED THE HOLE PRIOR TO PATIENT INJURY. THE SHUNT WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUNDT EXTERNAL CAROTID SHUNT CAROTID ENDARTERECTOMY SHUNTS DWF HEYER-SCHULTE NEUROCARE, INC. NL850-5070 1010176

    Patients

    Seq Age Sex Outcome Treatment
    1 *