BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARC-H II

    MDR report key: 814550 · Received January 24, 2007

    Report

    Report Number
    814550
    Event Type
    Malfunction
    Date Received
    January 24, 2007
    Date of Event
    January 11, 2007
    Report Date
    January 24, 2007
    Manufacturer
    BYRON MEDICAL INC.
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR, US

    Narratives

    Description of Event or Problem · 1

    RECIPROCATING HANDPIECE WOULD NOT RECIPROCATE. STAFF USED ANOTHER HANDPIECE. ALSO RECEIVED A SECOND HANDPIECE FROM ANOTHER CASE WITH THE SAME COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARC-H II CANNULA,RECIPROCATING HWE BYRON MEDICAL INC. ARC-H II 181-06

    Patients

    Seq Age Sex Outcome Treatment
    1 * NONE KNOWN.