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

Catalog Number	605700
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 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.
Additional Manufacturer Narrative
Investigation findings: lot# 00425272 invalid lot# / does not exist in ax system.Need return product.The device was not returned for evaluation and the lot number was not valid for retained-product testing and/or dhr review.Complaint will be reopened if suspect product or investigation result arrives per 8000-sop-038.

• Brand Name: JELT CHROMA F/S 454GM PCH
• 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: 18245586
• Report Number: 2515379-2023-00112
• Device Sequence Number: 12433731
• Product Code: ELW
• UDI-Device Identifier: D0026057001
• UDI-Public: D0026057001
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2024

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2023
• Supplement Date Received by Manufacturer: 11/27/2023
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown