MAUDE Adverse Event Report: NUPRO CRS W/FL ZINNAMON; AGENT, POLISHING, ABRASIVE,ORAL CAVITY, PRODUCT CODE:EJR

Catalog Number 801312

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Caustic/Chemical Burns (2549); Swelling/ Edema (4577)

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

While the customer was using nupro course w/flouride zinnamon, they allege that patient saw allergist and dermatologist for swelling of her lips 3 months ago; said she had chemical burn.The event outcome is unknown as of this mdr evaluation.

Manufacturer Narrative

Multiple unsuccessful attempts were made to obtain the device for evaluation.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.

• Brand Name: NUPRO CRS W/FL ZINNAMON
• Type of Device: AGENT, POLISHING, ABRASIVE,ORAL CAVITY, PRODUCT CODE:EJR
• MDR Report Key: 12519171
• MDR Text Key: 272919056
• Report Number: 2424472-2021-00056
• Device Sequence Number: 1
• Product Code: EJR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 801312
• Device Lot Number: 00000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/24/2021
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention