BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARKELL

    MDR report key: 22347209 · Received June 27, 2025

    Report

    Report Number
    2411797-2025-00001
    Event Type
    Injury
    Date Received
    June 27, 2025
    Date of Event
    April 1, 2025
    Report Date
    June 13, 2025
    Manufacturer
    PARKELL, INC
    Product Code
    ELC
    UDI-DI
    00810000522903
    PMA / PMN Number
    K950256
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DENTIST COMPLAINED THAT THE INSERT DID NOT FIT ON HANDPIECE. WE WERE UNABLE TO REPRODUCE THE COMPLAINT USING THE ACTUAL INSERT AND OUR SCALERS.. NO PROBLEM WAS FOUND. NO ISSUE TO USE INSERT AS INDICATED. WHEN WE WET THE INSERT AND TWISTED AS PER IFU THE INSERT HAD NO DIFFICULTY WITH INSERT OR REMOVAL.

    Description of Event or Problem · 0

    ON MAY 30, 2025, WE BECAME AWARE OF AN ADVERSE EVENT INVOLVING A DENTAL HYGIENIST WITH OUR DURA30-PS 30K DURATIP® PERIO SLIM INSERT. THIS INSERT IS AN ACCESSORY TO OUR "TURBO" ULTRASONIC SCALER. WHILE ATTEMPTING TO REMOVE THE INSERT FROM THE HANDHELD SHE WAS POKED BY THE SHARP TIP OF THE INSERT. NEITHER THE DENTIST NOR THE HYGIENIST WILL SHARE INFORMATION OF THE EVENT AND POSSIBLE TREATMENT DUE TO "HIPPA" RESTRICTIONS. WE WERE NOT NOTIFIED OF THE EVENT NOR ANY TREATMENT IN A TIMELY MANNER. WE ARE FILING THIS REPORT WITH AN OVERABUNDANCE OF CAUTION TO COMPLY WITH 21 CFR 803.10(C). THE HYGIENIST DID NOT FOLLOW IFU PRECAUTIONS OR OPERATING INSTRUCTIONS AS BELOW: "PRECAUTIONS" - WHEN INSERTING THE INSERT INTO THE HANDPIECE, ALWAYS USE A TWISTING MOTION. "OPERATING INSTRUCTIONS" - 2. FILL THE HANDPIECE WITH WATER ACCORDING TO THE SCALER MANUFACTURER'S INSTRUCTIONS. 3. LUBRICATE THE O-RING WITH WATER. 4. GENTLY TWIST THE INSERT WHILE INSERTING IT INTO A HANDPIECE UNTIL IT IS FULLY SEATED. SHE DID NOT TWIST, NOR DID SHE LUBRICATE THE HANDHELD OR THE O-RING. WE WILL FILE A FOLLOW-UP REPORT IF WE BECOME AWARE OF ANY ADDITIONAL RELEVANT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974086 PARKELL INSERT ELC PARKELL, INC DURA30-PS 202407 00810000522903

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Other