MAUDE Adverse Event Report: DENTSPLY LLC CAULK TRAY ADHESIVE REFILL; MATERIAL, IMPRESSION

Catalog Number	626155
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 report that a patient experienced an adverse reaction after undergoing a dental procedure that caulk tray adhesive was used.Reportedly, patient presented with mild respiratory difficulty.Patient does have known allergies to latex and certain type of fish.The outcome of this event is unknown as of this mdr.Further information requested.
Additional Manufacturer Narrative
Investigation: investigation type: retain, pass; investigation type: dhr, dhr's within specification.626155, lot#: 00089107, fg; 926156, lot#: 00085195, filled; 926109, lot#: 00084243, bulk.Failure mode: possible allergic reaction; root cause: not determined; conclusion code: indeterminable.

• Brand Name: CAULK TRAY ADHESIVE REFILL
• 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: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 17821432
• Report Number: 2515379-2023-00101
• Device Sequence Number: 2440769
• Product Code: ELW
• UDI-Device Identifier: D0026261550
• UDI-Public: D0026261550
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K781151
• 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): 12/28/2023

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: 626155
• Device Lot Number: 85195
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/22/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2023
• Supplement Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown