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

Catalog Number 626155

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

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 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.

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
• Type of Device: 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
• MDR Text Key: 324304047
• Report Number: 2515379-2023-00101
• Device Sequence Number: 1
• Product Code: ELW
• UDI-Device Identifier: D0026261550
• UDI-Public: D0026261550
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K781151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 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
• Initial Date Manufacturer Received: 09/22/2023
• Initial Date FDA Received: 09/26/2023
• Supplement Dates Manufacturer Received: 09/22/2023
• Supplement Dates FDA Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1