BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HU-FRIEDY

    MDR report key: 312039 · Received January 11, 2001

    Report

    Report Number
    1416605-2001-00001
    Event Type
    Injury
    Date Received
    January 11, 2001
    Date of Event
    November 1, 2000
    Report Date
    January 10, 2001
    Manufacturer
    HU-FRIEDY MFG. CO.,INC.
    Product Code
    ELC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DENTIST WAS USING AN ULTRASONIC SCALER ON A PT. THE TIP APPARENTLY BROKE DURING THE PROCEDURE. (NOTE: NO INFO REGARDING USE OF X-RAYS TO LOCATE THE TIP FRAGMENT WAS PROVIDED.) THE DOCTOR ELECTED TO PERFORM A FLAP PROCEDURE TO EXTRACT THE TIP FRAGMENT, AND DID THE FLAP PROCEDURE. NO TIP FRAGMENT WAS EXTRACTED, HOWEVER. THE SITE WAS CLOSED (PRESUMABLY WITH SUTURES, HOWEVER THIS WAS NOT STATED). IT WAS FURTHER REPORTED THAT THIS PT SUFFERED A HEART ATTACK AND STROKE THE NEXT DAY. NO INFO WAS PROVIDED AS TO THE PT'S PRIOR MEDICAL CONDITION. THE CAUSE OF THE HEART ATTACK/STROKE WAS NOT INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1177 HU-FRIEDY ULTRASONIC SCALER TIP ELC HU-FRIEDY MFG. CO.,INC. UI30KFS M9

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention