BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    **NUPRO REVOLV 90D SOFT MULTI (PD)

    MDR report key: 22327582 · Received June 25, 2025

    Report

    Report Number
    2424472-2025-00235
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Date of Event
    June 24, 2025
    Report Date
    September 19, 2025
    Manufacturer
    DENTSPLY LLC
    Product Code
    EGS
    UDI-DI
    D0039652501
    PMA / PMN Number
    K030603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE IT IS UNKNOWN IF THE DEVICE USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PATIENT¿S SYMPTOMS, IT IS POSSIBLE AS ALLERGIC REACTIONS TO DENTAL MATERIALS ARE KNOWN AND REPORTED, WITH MEDICAL CONSEQUENCES BEING DEPENDENT UPON THE SEVERITY OF THE INDIVIDUAL ALLERGIC RESPONSE AND SUBSEQUENT EXPOSURE TO THE SAME MATERIAL. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.

    Additional Manufacturer Narrative · 0

    ALLERGIC REACTION CHECKLIST WAS NEVER RECEIVED FROM THE CUSTOMER TO FURTHER EVALUATE THIS INCIDENT. IF ADDITIONAL INFORMATION IS RECEIVED, WE WILL REOPEN THE COMPLAINT FOR FURTHER INVESTIGATION. ROOT CAUSE IS INCONCLUSIVE DUE TO NOT ENOUGH INFORMATION WAS PROVIDED BY THE CUSTOMER. FAILURE MODE - POSSIBLE ALLERGIC REACTION. ROOT CAUSE - CUSTOMER DID NOT READ/FOLLOW INSTRUCTIONS. CONCLUSION CODE - INDETERMINABLE.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT NUPRO REVOLV 90D SOFT MULTI (PD) IS ALLEGED THAT PATIENT HAD AN ALLERGIC REACTION TO SOMETHING DURING THEIR CLEANING. THE HYGIENIST THINKS IT IS THE PROPHY CUP USED DURING THE POLISHING OF THE PATIENTS¿ TEETH. A DENTSPLY SIRONA NUPRO FREEDOM- REVOLVE PROPHY CUP WAS USED WITH A NON-DENTSPLY SIRONA POLISHING PASTE. PATIENT WILL SEE HER ALLERGIST IN (B)(6) 2025, AS THIS IS THE SOONEST APPOINTMENT AVAILABLE". NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1368684 **NUPRO REVOLV 90D SOFT MULTI (PD) HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS DENTSPLY LLC UNKNOWN D0039652501

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown