BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HU-FRIEDY

    MDR report key: 197769 · Received November 17, 1998

    Report

    Report Number
    197769
    Event Type
    Injury
    Date Received
    November 17, 1998
    Date of Event
    October 13, 1998
    Report Date
    October 22, 1998
    Manufacturer
    HU-FRIEDY MFG. CO.,INC.
    Product Code
    EMN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING DENTAL PROCEDURE 1 TO 1.5 CM OF TIP OF POSTERIOR UNIVERSAL HAND SCALER BROKE OFF IN PT'S MOUTH. ATTEMPTS TO RECOVER BY SUCTION WERE UNSUCCESSFUL. CHEST X-RAY REVEALED ASPIRATION INTO LEFT LUNG. OBJECT WAS SURGICALLY REMOVED. PT RETURNED TO HOME THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HU-FRIEDY MCCALL DOUBLE-ENDED SCALER EMN HU-FRIEDY MFG. CO.,INC. SM 13/14S NA

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention