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

Catalog Number 801329

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Reaction (2414)

Event Type  Injury  

Event Description

In this event it was reported that a pediatric patient with many allergies, experienced nausea and vomiting following treatment with nupro prophy paste (chocolate bliss flavor).The patient's mother was sent a list of ingredients in order to have allergy testing done.Results are not available as of this report.

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.

• 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; york, PA 17404 ; 7178457511
• MDR Report Key: 4860132
• MDR Text Key: 19347763
• Report Number: 2424472-2015-00034
• Device Sequence Number: 1
• Product Code: EJR
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Type of Report: Initial
• Report Date: 05/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 801329
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/22/2015
• 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