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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Manufacturer Narrative

Hold for ljbp 2.11.2021 the device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.

Event Description

While the customer was using a nupro prophylaxis paste (unknown catalog number and lot number) , there was a loss of pigment around the patient's mouth after cleaning with nupro prophylaxis paste.The event outcome is unknown as of this mdr evaluation.

• Brand Name: NUPRO PROPHY PASTE
• Type of Device: AGENT, POLISHING, ABRASIVE, ORAL CAVITY
• Manufacturer (Section D): DENTSPLY LLC; 1301 smile way; york PA 17404
• Manufacturer (Section G): DENTSPLY LLC; 1301 smile way; york PA 17404
• Manufacturer Contact: karl nittinger ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494424
• MDR Report Key: 11319768
• MDR Text Key: 231572872
• Report Number: 2424472-2021-00001
• Device Sequence Number: 1
• Product Code: EJR
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other