MAUDE Adverse Event Report: DENTSPLY LLC NUPRO PROPHY PASTE WITH FLUORIDE, ZINNAMON, COARSE; AGENT, POLISHING, ABRASIVE, ORAL CAVITY

Catalog Number 801312

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

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.Multiple unsuccessful attempts were made to obtain the patient outcome.

Event Description

While using nupro crs w/fl (zinnamon), a patient had an "anaphylactic reaction." the patient was treated by their pcp.The event outcome is unknown as of this mdr evaluation.

• Brand Name: NUPRO PROPHY PASTE WITH FLUORIDE, ZINNAMON, COARSE
• Type of Device: AGENT, POLISHING, ABRASIVE, ORAL CAVITY
• Manufacturer (Section D): DENTSPLY LLC; 1301 smile way; york, pa
• Manufacturer (Section G): DENTSPLY CAULK; 38 w. clark ave.; milford, de
• Manufacturer Contact: karl nittinger ; 221 w. philadelphia st.; suite 60w; york, pa ; 8494424
• MDR Report Key: 9817727
• MDR Text Key: 192154606
• Report Number: 2424472-2020-00015
• Device Sequence Number: 1
• Product Code: EJR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 801312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention