BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGULATED BRACKET REMOVING PLIERS, LONG HANDLE

    MDR report key: 14379924 · Received May 12, 2022

    Report

    Report Number
    1416605-2022-00003
    Event Type
    Malfunction
    Date Received
    May 12, 2022
    Report Date
    May 12, 2022
    Manufacturer
    HU-FRIEDY MFG. CO. LLC
    Product Code
    JEX
    UDI-DI
    10889950003456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO REPORT OF MALFUNCTION OF OUR DEVICE ASSOCIATED WITH THE EVENT. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ABNORMALITIES WERE NOTED. THE DEVICE SUBJECT OF THE EVENT WAS REQUESTED TO BE RETURNED TO HU-FRIEDY FOR EVALUATION. TO DATE, THE DEVICE HAS NOT BEEN RETURNED. A FOLLOW-UP MDR WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE

    Additional Manufacturer Narrative · 0

    THE DEVICE SUBJECT OF THE EVENT WAS RETURNED FOR EVALUATION AND NO ISSUES WERE NOTED. THERE WAS NO REPORT OF MALFUNCTION OF OUR DEVICE ASSOCIATED WITH THE EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT A PATIENT'S TOOTH BROKE DURING A DENTAL PROCEDURE WHICH INCLUDED USE OF AN ANGULATED BRACKET REMOVING PLIERS. THE PATIENT'S TOOTH WAS RECEMENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580262 ANGULATED BRACKET REMOVING PLIERS, LONG HANDLE PLIER JEX HU-FRIEDY MFG. CO. LLC 678-220L 0122 10889950003456

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown