MAUDE Adverse Event Report: DENTSPLY LLC COMFIT SUPER SENSITIVE EAR LOOP WHITE - BOX OF 50 EA; MASK, SURGICAL

Catalog Number	20346
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Malfunction
Event or Problem Description
In this event, it is reported that during use of comfit super sensitive ear loop white - box of 50 ea, it is alleged that an allergic reaction occurred.No injury.
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.Investigation results: root cause determination was not possible due to insufficient complaint detail of dispenser lot code.There were no deviations identified from the specifications or operating parameters.No adverse trends were observed against product 20346.Failure mode - allergic reaction.Root cause - not determined - no additional information was provided by the customer, and no root cause was determined as a part of the supplier's investigation with the information provided by the customer.Conclusion code - no failure found.
Additional Manufacturer Narrative
Root cause of the reaction is unknown.Upon review of the batch records by the supplier, no non-conformances were identified from the investigation (see attachment "#600 serious complaint nov 2025" for supplier report).Upon review of the risk documentation, it was identified that the risk associated with allergic reactions and skin irritation have been identified and reduced as far as possible by the product design.Failure mode - allergic reaction.Root cause - not determined.Conclusion code - no failure found.

• Brand Name: COMFIT SUPER SENSITIVE EAR LOOP WHITE - BOX OF 50 EA
• Common Device Name: MASK, SURGICAL
• 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: 23758773
• Report Number: 2424472-2025-00269
• Device Sequence Number: 15936224
• Product Code: FXX
• UDI-Device Identifier: D687203461
• UDI-Public: D687203461
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K061716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 20346
• Device Lot Number: 21171646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2025
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/21/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown