BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HU-FRIEDY MFG. CO., LLC

    MDR report key: 5648603 · Received May 11, 2016

    Report

    Report Number
    1416605-2016-00002
    Event Type
    Injury
    Date Received
    May 11, 2016
    Date of Event
    April 5, 2016
    Report Date
    April 29, 2016
    Manufacturer
    HU-FRIEDY MFG. CO., LLC
    Product Code
    EKB
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION DETERMINED THE INSTRUMENT WAS MANGLED AND WELL PAST ITS LIFE EXPECTANCY BASED ON THE WEAR ON THE WORKING END AND THE MANUFACTURING DATE CODE. THE INSTRUMENT ALSO APPEARED TO BE RE-TIPPED BASED ON THE BENDS OF THE #17 EXPLORER NOT MATCHING THE SHAPE OF THE HU-FRIEDY BRAND. DATE OF BIRTH OF PATIENT IS UNKNOWN. WEIGHT OF PATIENT IS UNKNOWN. NO RELEVANT MEDICAL HISTORY. HU-FRIEDY DOES NOT TRACK OUR DEVICES, WHICH ARE MOSTLY LOW RISK CLASS 1 DEVICES, BY SERIAL NUMBER, ONLY A LOT NUMBER WHICH IS TIED TO THE DATE OF MANUFACTURE. THE PRODUCT INVOLVED IN THE EVENT DOES NOT HAVE AN EXPIRATION DATE. THE DEVICE IS NOT IMPLANTED. THE DEVICE IS NOT EXPLANTED. NOT APPLICABLE. NO CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES. THE (A) NDA NUMBER, BLA NUMBER AND 510 (K) NUMBER ARE NOT APPLICABLE TO THIS CLASS 1 DEVICE. NO PROTOCOL NUMBERS ARE RELEVANT. THIS IS NOT A FOLLOW-UP. THIS IS AN INITIAL REPORT. NO REMEDIAL ACTION INITIATED. NO CORRECTION/REMOVAL INITIATED.

    Description of Event or Problem · 1

    DURING A STANDARD EXAM, THE DOCTOR WAS LOOKING FOR CAVITIES AND THE TIP OF THE INSTRUMENT BROKE IN THE PATIENT'S MOUTH. THE PATIENT SWALLOWED THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303434 HU-FRIEDY MFG. CO., LLC EXPLORER EKB HU-FRIEDY MFG. CO., LLC EXD56 V4

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization| O