MAUDE Adverse Event Report: DENTSPLY CAULK AQUASIL ULTRA DECA HEAVY FAST SET STANDARD PACK-LIGHT GREEN; MATERIAL, IMPRESSION

Catalog Number 678784

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Reaction (2414)

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

It was reported that a patient experienced an allergic reaction after undergoing a crown procedure with aquasil ultra impression material.No intervention was required.

Manufacturer Narrative

The device was evaluated and found to be within specification.

• Brand Name: AQUASIL ULTRA DECA HEAVY FAST SET STANDARD PACK-LIGHT GREEN
• Type of Device: MATERIAL, IMPRESSION
• Manufacturer (Section D): DENTSPLY CAULK; 38 w. clark ave.; milford DE 19963
• MDR Report Key: 8395200
• MDR Text Key: 137982913
• Report Number: 2515379-2019-00002
• Device Sequence Number: 1
• Product Code: ELW
• Combination Product (y/n): N
• PMA/PMN Number: K113406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2019

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 Operator: Health Professional
• Device Catalogue Number: 678784
• Device Lot Number: 00002817
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/31/2019
• Initial Date FDA Received: 03/06/2019
• Supplement Dates Manufacturer Received: 04/14/2019
• Supplement Dates FDA Received: 04/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other