MAUDE Adverse Event Report: DENTSPLY LLC MED ORANGE W/O JAR NUPRO; AGENT, POLISHING, ABRASIVE, ORAL CAVITY

Catalog Number	801120
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 was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
Event or Problem Description
In this event it is reported that while a customer was using med orange w/o jar nupro, they allege that a patient experienced a allergic reaction - pins and needles feeling and slightly swollen face.Reportedly, no injury was reported from the alleged event.
Additional Manufacturer Narrative
Additional information: adding udi# (b)(4).This is a follow up report to add this information.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.- unable to investigate.Unknown lot #.

• Brand Name: MED ORANGE W/O JAR NUPRO
• Common Device Name: AGENT, POLISHING, ABRASIVE, ORAL CAVITY
• Manufacturer (Section D): DENTSPLY LLC; 1301 smile way; york PA 17404
• Manufacturer (Section G): DENTSPLY LLC; 1301 smile way; york PA 17404
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 17078023
• Report Number: 2424472-2023-00382
• Device Sequence Number: 2250328
• Product Code: EJR
• UDI-Device Identifier: D0038011201
• UDI-Public: D0038011201
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2023

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?: Yes
• Device Catalogue Number: 801120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/02/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/02/2023
• Supplement Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown