BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCALER SYSTEM, PERIODONTIC, ULTRASONIC

    MDR report key: 2011564 · Received March 7, 2011

    Report

    Report Number
    3004096429-2011-00002
    Event Type
    Injury
    Date Received
    March 7, 2011
    Date of Event
    May 27, 2010
    Report Date
    March 4, 2011
    Manufacturer
    ELECTRO MEDICAL SYSTEMS S.A.
    Product Code
    ELC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EMS KNOW OF NO RELATIONSHIP BETWEEN THE SYMPTOMS OF TINNITUS AND THE SCALING PROCEDURE PERFORMED USING THE MINIMASTER DEVICE. IN THE MANY YRS EMS HAS MARKETED THE PIEZON TECHNOLOGY, WE HAVE NOT REC'D ANY SIMILAR REPORT.

    Description of Event or Problem · 1

    IN PERFORMING SCALING WITH MINIMASTER DEVICE, WHEN THE HYGIENIST APPLIED THE TIP AGAINST TOOTH NR 18, THE PT REACTED WITH A STRONG REFLEX. THE PT CLAIMED BY BEING IMMEDIATELY SUFFERING FROM TINNITUS. "A DENTAL HYGIENIST WAS ABOUT TO PERFORM SCALING WITH AN EMS MINIMASTER ON A PT. WHEN SHE APPLIED THE TIP AGAINST TOOTH NR 18, THE PT REACTED WITH A STRONG REFLEX. THE PT CLAIMED BY BEING IMMEDIATELY SUFFERING FROM TINNITUS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCALER SYSTEM, PERIODONTIC, ULTRASONIC MINIMASTER ELC ELECTRO MEDICAL SYSTEMS S.A. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other