BEUDAMED
    FDA Adverse Event Other Summary report: N

    HU-FRIEDY BRACKET REMOVER

    MDR report key: 2625834 · Received June 11, 2012

    Report

    Report Number
    1416605-2012-00002
    Event Type
    Other
    Date Received
    June 11, 2012
    Date of Event
    March 23, 2012
    Report Date
    June 1, 2012
    Product Code
    EJB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE PATIENT WAS HAVING BRACKETS REMOVED, THE PLIER BEING USED BROKE AND CAUSED A HORIZONTAL FRACTURE ON TOOTH NUMBER 12. THE TOOTH WAS TEMPORARY FIXED AND THE PATIENT WAS SENT TO THE (B)(6) MEDICAL CENTER OF THE UNIVERSITY OF (B)(6) WHERE A ROOT CANAL TREATMENT WAS PERFORMED ON TOOTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HU-FRIEDY BRACKET REMOVER 678-220L EJB 678-220L T5

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other