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

Catalog Number 801120

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

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 was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 316673928
• Report Number: 2424472-2023-00382
• Device Sequence Number: 1
• Product Code: EJR
• UDI-Device Identifier: D0038011201
• UDI-Public: D0038011201
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• 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
• Date Manufacturer Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1