BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HU-FRIEDY #9 DEAN SCISSORS

    MDR report key: 7481761 · Received May 2, 2018

    Report

    Report Number
    1416605-2018-00003
    Event Type
    Injury
    Date Received
    May 2, 2018
    Date of Event
    April 2, 2018
    Report Date
    July 20, 2018
    Manufacturer
    HU-FRIEDY MFG. CO., LLC
    Product Code
    EGN
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IN QUESTION WAS RETURNED TO HU-FRIEDY MFG. CO., LLC AFTER THE INITIAL REPORT WAS FILED. ANALYSIS OF THE RETURNED INSTRUMENT REVEALED THAT IT WAS PAST ITS LIFE EXPECTANCY. LOT NUMBER HAS BEEN UPDATED. DEVICE WAS RETURNED TO MANUFACTURER. THIS IS A FOLLOW-UP REPORT THIS FOLLOW-UP REPORT PROVIDES ADDITIONAL INFORMATION AND DEVICE EVALUATION. DEVICE WAS RETURNED TO MANUFACTURER. DEVICE MANUFACTURE DATE HAS BEEN PROVIDED. H6 - METHOD, RESULT AND CONCLUSION CODES HAVE BEEN UPDATED.

    Additional Manufacturer Narrative · 1

    THERE IS NO RELEVANT HISTORY. HU-FRIEDY DOES NOT TRACK OUR DEVICES (WHICH ARE MOSTLY LOW RISK CLASS 1 DEVICES) BY SERIAL NUMBER OR UDI, ONLY BY A LOT NUMBER, WHICH IS TIED TO THE DATE OF MANUFACTURE. IN THIS INSTANCE, THE LOT NUMBER IS WAS NOT PROVIDED BY THE INITIAL REPORTER. THE DEVICE INVOLVED IN THE EVENT DOES NOT HAVE AN EXPIRATION DATE. THE DEVICE IS NOT IMPLANTED, THEREFORE IMPLANT/EXPLANT DATES ARE NOT APPLICABLE. NO KNOWN CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES. PMA/510(K) IS NOT APPLICABLE. THE DEVICE MANUFACTURE DATE IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED TO HU-FRIEDY CO., LLC THAT DURING AN ORAL SURGERY PROCEDURE, THE INSTRUMENT BROKE IN THE PATIENT'S MOUTH. THE BROKEN TIP WAS SWALLOWED. THE BROKEN TIP WAS LATER RETRIEVED FROM THE SMALL INTESTINE USING AN ENDOSCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322178 HU-FRIEDY #9 DEAN SCISSORS SCISSORS, SURGICAL TISSUE, DENTAL EGN HU-FRIEDY MFG. CO., LLC S9 0510

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| O