BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARBON SURGICAL BLDS 15C

    MDR report key: 842433 · Received April 13, 2007

    Report

    Report Number
    2523190-2007-00004
    Event Type
    Malfunction
    Date Received
    April 13, 2007
    Report Date
    April 13, 2007
    Manufacturer
    KAI INDUSTRIES CO. LTD.
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT, THE LIPS AND CORNERS OF PTS' MOUTHS ARE BEING LACERATED DURING PERIODONTAL PROCEDURES, WHEN USING BLADES. NONE OF THE LACERATIONS REQUIRED FURTHER TREATMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARBON SURGICAL BLDS 15C * GFA KAI INDUSTRIES CO. LTD. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *