MAUDE Adverse Event Report: DENTSPLY LLC FINE MINT W/F CUPS NUPRO; AGENT, POLISHING, ABRASIVE, ORAL CAVITY

Catalog Number	801232
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
In this event it is reported that a patient had an reaction to the fine mint w/f cups nupro after a recent dental cleaning.No injury was reported after the alleged event.
Additional Manufacturer Narrative
Investigation results: none of the nupro mint products (mint, spearmint, or peppermint), contain pvp.An email was sent confirming this to (b)(6), (b)(6), and (b)(6) with (b)(6) and (b)(6) on copy on (b)(6) 2025.The compositions that were checked and provided were the following part numbers: (b)(6).Failure mode: patient reaction.Root cause: not determined.It is not possible to determine if the allergic reaction was caused by the prophy paste.Conclusion code: indeterminable.

• Brand Name: FINE MINT W/F CUPS NUPRO
• Common Device Name: AGENT, POLISHING, ABRASIVE, ORAL CAVITY
• Manufacturer (Section D): DENTSPLY LLC; 1301 smile way; york PA 17404
• Manufacturer (Section G): DENTSPLY LLC; 1301 smile way; york PA 17404
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 21190400
• Report Number: 2424472-2025-00202
• Device Sequence Number: 18214015
• Product Code: EJR
• UDI-Device Identifier: D0038012321
• UDI-Public: D0038012321
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 801232
• Device Lot Number: 000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/03/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/20/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown