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

Catalog Number 801222

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Asthma (1726); Reaction (2414)

Event Date 01/04/2015

Event Type  Injury  

Event Description

In this event it was reported that after using nupro prophy paste, a pt experienced an asthmatic episode, which the doctor thinks may be due to an allergy to one of the ingredients in the prophy paste.The pt was able to treat himself with a "spray".

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: AGENT, POLISHING, ABRASIVE, ORAL CAV
• 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: 4527485
• MDR Text Key: 5358999
• Report Number: 2424472-2015-00003
• Device Sequence Number: 1
• Product Code: EJR
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 801222
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2015
• 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
• Treatment: ELMEX FLUORIDE DROPS
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR