MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL NUPRO EXTRA CARE PROPHY PASTE, SPEARMINT POLISH WITH FLUORIDE; AGENT, POLISHING, ABRASIVE, ORAL CAVITY

Catalog Number 801600

Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problems Hypersensitivity/Allergic reaction (1907); Swelling (2091); Tingling (2171); Reaction (2414)

Event Date 05/23/2016

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.This report is for the second patient.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

Event Description

It was reported that two patient's experienced an allergic reaction following treatment with nupro extra care polish spearmint.In the second patient, they reported that their tongue felt "tingly and big".The patient declined benadryl.The patient's symptoms abated approximately 30 minutes after treatment was completed.

Manufacturer Narrative

Multiple unsuccessful attempts were made to obtain the device for evaluation.Retain product was tested and found to be within specification.Also, a dhr review was conducted with no discrepancies noted.

• Brand Name: NUPRO EXTRA CARE PROPHY PASTE, SPEARMINT POLISH WITH FLUORIDE
• Type of Device: AGENT, POLISHING, ABRASIVE, ORAL CAVITY
• Manufacturer (Section D): DENTSPLY PROFESSIONAL; 1301 smile way; york PA 17404
• Manufacturer (Section G): DENTSPLY CAULK; 38 w. clark ave.; milford DE 19963
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 5743266
• MDR Text Key: 47997975
• Report Number: 2424472-2016-00047
• Device Sequence Number: 1
• Product Code: EJR
• Combination Product (y/n): N
• PMA/PMN Number: K121698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 801600
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/22/2016
• 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
• Patient Age: 42 YR