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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943)

Event Type  Injury  

Event Description

In this event it was reported that a pediatric pt experienced an allergic reaction after a dental procedure that included the use of nupro prophy paste.The reported symptoms included itching and watery eyes.The pt was treated with cortisone and antihistamines.All symptoms disappeared after treatment was stopped.

Manufacturer Narrative

While it is unk if the device used in this case caused or contributed to the pt'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 eval, though has not been returned as of this report.Eval results will be submitted as they become available.

• 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 17401 ; 7178457511
• MDR Report Key: 4694059
• MDR Text Key: 5645612
• Report Number: 2424472-2015-00016
• Device Sequence Number: 1
• Product Code: EJR
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 03/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2015
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention