MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL NUPRO PROPHY PASTE; ORAL CAVITY ABRASIVE POLISHING AGENT

Catalog Number 801211

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Swelling (2091); Reaction (2414)

Event Type  Injury  

Event Description

In this event it was reported that while using nupro prophy paste (orange), a patient began to experience an allergic reaction.The patient has a known allergy to red dyes and her lips began to swell upon initial use.The patient did not require medical intervention.

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.

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 PROPHY PASTE
• Type of Device: ORAL CAVITY ABRASIVE POLISHING AGENT
• Manufacturer (Section D): DENTSPLY PROFESSIONAL; york PA
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st., ste 60; susquehanna commerce ctr w.; york, PA 17401 ; 7178457511
• MDR Report Key: 4702898
• MDR Text Key: 5644314
• Report Number: 2424472-2015-00013
• Device Sequence Number: 1
• Product Code: EJR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 03/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 801211
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other