MAUDE Adverse Event Report: DENTSPLY LLC JELT CHROMA F/S 454GM PCH; MATERIAL, IMPRESSION

Catalog Number 605700

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Event Description

In this event it is reported allergic reaction to students reportedly occurred using jelt chroma f/s 454gm pch/jeltrate chroma dustless alginate - for use by the students during this academic year.The students experienced adverse reactions including ulcers, blisters, and mucositis after using the product.Further information requested.

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.

Manufacturer Narrative

The device was evaluated and found to be within specification.Retain product was also evaluated and found to be in specification.

• Brand Name: JELT CHROMA F/S 454GM PCH
• 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: 18245784
• MDR Text Key: 329477411
• Report Number: 2515379-2023-00115
• Device Sequence Number: 1
• Product Code: ELW
• UDI-Device Identifier: D0026057001
• UDI-Public: D0026057001
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

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: 605700
• Device Lot Number: 425272
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/27/2023
• Initial Date Manufacturer Received: 11/27/2023
• Initial Date FDA Received: 12/01/2023
• Supplement Dates Manufacturer Received: 11/27/2023
• Supplement Dates FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1