MAUDE Adverse Event Report: DENTSPLY LLC AQUA ULTRA + HB FS 5:1 2PCK; MATERIAL, IMPRESSION

Catalog Number	678684
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Serious 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.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
Event or Problem Description
In this event it is reported that a patient allegedly had an allergic reaction to aqua ultra + hb fs 5:1 2pck.Patient has a known allergy to yellow dye.Further information requested.
Additional Manufacturer Narrative
Investigation results: unable to investigate - lot number unknown.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.

• Brand Name: AQUA ULTRA + HB FS 5:1 2PCK
• Common Device Name: MATERIAL, IMPRESSION
• Manufacturer (Section D): DENTSPLY LLC; 38 west clarke avenue; milford DE 19963
• Manufacturer (Section G): DENTSPLY LLC; 38 west clarke avenue; milford DE 19963
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 22307869
• Report Number: 2515379-2025-00012
• Device Sequence Number: 8081797
• Product Code: ELW
• UDI-Device Identifier: D0026786841
• UDI-Public: D0026786841
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K152861
• 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): 09/26/2025

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?: No
• Device Catalogue Number: 678684
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/19/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/19/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown