MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL NUPRO PROPHY PASTE COURSE MINT FLUORIDE CUPS; AGENT, POLISHING, ABRASIVE, ORAL CAVITY

Catalog Number 801212

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

It was reported that a patient, who is allergic to some dyes, had a reaction after use of nupro prophy paste.Reported symptoms include a headache, stomach pain and trouble breathing.The patient stated they did not seek medical attention because she has previously had this issue.

• Brand Name: NUPRO PROPHY PASTE COURSE MINT FLUORIDE CUPS
• Type of Device: AGENT, POLISHING, ABRASIVE, ORAL CAVITY
• Manufacturer (Section D): DENTSPLY PROFESSIONAL; 1301 smile way; york PA 17404
• Manufacturer (Section G): DENTSPLY PROFESSIONAL; 1301 smile way; york PA 17404
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 6264970
• MDR Text Key: 65312890
• Report Number: 2424472-2016-00105
• Device Sequence Number: 1
• Product Code: EJR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 801212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other