BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRECISE LTM DIODE LASER

    MDR report key: 2577619 · Received May 4, 2012

    Report

    Report Number
    1725006-2012-00002
    Event Type
    Other
    Date Received
    May 4, 2012
    Date of Event
    April 16, 2012
    Report Date
    May 2, 2012
    Manufacturer
    CAO GROUP, INC.
    Product Code
    LYB
    PMA / PMN Number
    K050453
    Removal / Correction Number
    NONE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVOLVED IN INCIDENT IS TEMPORARILY ON LOAN TO THE HEALTH CARE PROVIDER WHILE THEIR USUAL UNIT IS BEING REPAIRED FOR AN UNRELATED ISSUE. HEALTH CARE PROVIDER INDICATED THAT THE PROCEDURE BEING PERFORMED WHEN THIS EVENT OCCURRED WAS THE FIRST TIME THAT THE HYGIENIST HAS USED THIS DEVICE FOR A PERIODONTAL DEBRIDEMENT PROCEDURE. HEALTH CARE PROVIDER HAS USED THIS DEVICE ON PREVIOUS PROCEDURES. MANUFACTURER IS UNAWARE OF THE TRAINING STATUS OR SUPERVISION AFFORDED TO THE HYGIENIST SURROUNDING THIS EVENT. AS OF THE DATE OF THIS REPORT, THE HEALTH CARE PROVIDER'S USUAL UNIT HAS BEEN REPAIRED AND RETURNED, AND THE MANUFACTURER IS AWAITING RETURN OF THE SUSPECT DEVICE FOR EVAL. MANUFACTURER ADVISED THE HEALTH CARE PROVIDER TO CONDUCT PERIODIC FOLLOW-UP WITH THE PT TO DETERMINE IF ANY ADDITIONAL PROBLEMS AROSE RELATED TO THIS EVENT. NO REPORTS OF ANY ADDITIONAL ISSUES FROM THESE FOLLOW-UP ACTIVITIES.

    Description of Event or Problem · 1

    DENTAL HYGIENIST WAS PERFORMING A PERIODONTAL DEBRIDEMENT PROCEDURE. DURING THE PROCEDURE, A 6MM LENGTH OF OPTICAL FIBER BROKE OFF OF THE HANDPIECE TIP AND WAS SWALLOWED BY THE PT. PT WAS NOT AWARE AT THE TIME THAT THE FIBER HAD BEEN INGESTED. PT HAS NOT REPORTED ANY EVENTS OR ADVERSE HEALTH OUTCOMES ATTRIBUTABLE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE LTM DIODE LASER LASER SURGICAL DEVICE LYB CAO GROUP, INC. 002-00176

    Patients

    Seq Age Sex Outcome Treatment
    1 Other