MAUDE Adverse Event Report: DENTSPLY CAULK JELTRATE ALGINATE IMPRESSION MATERIAL-FAST SET; MATERIAL, IMPRESSION

Catalog Number 608247

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

In this event it was reported that a patient experienced allergic reaction after undergoing an impression procedure with jeltrate alginate impression material.Its reported that the reaction subsided on its own without any serious injuries and no additional follow up is required at this time.

Manufacturer Narrative

The device was evaluated and found to be within specification.A dhr review was conducted with no discrepancies noted.

• Brand Name: JELTRATE ALGINATE IMPRESSION MATERIAL-FAST SET
• Type of Device: MATERIAL, IMPRESSION
• Manufacturer (Section D): DENTSPLY CAULK; 38 w. clark ave.; milford DE 19963
• MDR Report Key: 8511797
• MDR Text Key: 141909206
• Report Number: 2515379-2019-00006
• Device Sequence Number: 1
• Product Code: ELW
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/24/2019

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: 608247
• Device Lot Number: 00003634
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/13/2019
• Initial Date FDA Received: 04/12/2019
• Supplement Dates Manufacturer Received: 04/26/2019
• Supplement Dates FDA Received: 05/24/2019
• Patient Sequence Number: 0
• Patient Outcome(s): Other