BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HU-FRIEDY STREAMLINE DIRECT FLOW, 30K

    MDR report key: 6498167 · Received April 17, 2017

    Report

    Report Number
    1416605-2017-00002
    Event Type
    Malfunction
    Date Received
    April 17, 2017
    Date of Event
    March 20, 2017
    Report Date
    April 10, 2017
    Manufacturer
    HU-FRIEDY MFG. CO., LLC
    Product Code
    ELC
    PMA / PMN Number
    K012060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT HISTORY: NO RELEVANT MEDICAL HISTORY. THE DEVICE WAS PRODUCED BEFORE THE UDI COMPLIANCE DUE DATE FOR THE PRODUCT AND THEREFORE UDI WAS NOT APPLIED. THE PRODUCT INVOLVED IN THE EVENT DOES NOT HAVE AN EXPIRATION DATE. IMPLANT DATE: THE DEVICE IS NOT IMPLANTED. EXPLANT DATE: THE DEVICE IS NOT EXPLANTED. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES ARE UNKNOWN. PMA 510(K): THE (A) NDA NUMBER AND BLA NUMBER ARE NOT APPLICABLE TO THIS CLASS 2 DEVICE. NO PROTOCOL NUMBERS ARE RELEVANT. IF FOLLOW US WHAT TYPE: THIS IS NOT A FOLLOW-UP. THIS IS AN INITIAL REPORT. NO REMEDIAL ACTION INITIATED. NO CORRECTION/REMOVAL INITIATED.

    Additional Manufacturer Narrative · 1

    BRAND NAME HAS BEEN UPDATED. THIS IS A FOLLOW-UP REPORT. FOLLOW-UP TYPE HAS BEEN UPDATED. CONCLUSION CODE HAS BEEN UPDATED.

    Additional Manufacturer Narrative · 1

    THE MODEL NUMBER AND CATALOG NUMBER ON THE INITIAL REPORT WAS INCORRECTLY REPORTED TO US BY THE INITIAL REPORTER. THIS UPDATE IS TO CORRECT THE MODEL AND CATALOG NUMBER INVOLVED IN THIS ADVERSE INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO HU-FRIEDY MFG. CO., LLC THAT THE HYGIENIST WAS PERFORMING A SCALING AND ROOT PLANING PROCEDURE WHEN THE TIP OF THE INSTRUMENT BROKE IN THE PATIENT'S MOUTH. THE PATIENT REPORTEDLY SWALLOWED THE TIP.

    Description of Event or Problem · 1

    IT WAS REPORTED TO HU-FRIEDY MFG. CO., LLC THAT THE HYGIENIST WAS PERFORMING A SCALING AND ROOT PLANING PROCEDURE WHEN THE TIP OF THE INSTRUMENT BROKE IN THE PATIENT'S MOUTH. THE PATIENT REPORTEDLY SWALLOWED THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279416 HU-FRIEDY STREAMLINE DIRECT FLOW, 30K ULTRASONIC SCALER, PRODUCT CODE: ELC ELC HU-FRIEDY MFG. CO., LLC UI30SFXT 0316

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other