MAUDE Adverse Event Report: DENTSPLY LLC PROPHY-JET PROPHY POWDER WITH SODIUM BICARBONATE; SCALER, ULTRASONIC

Catalog Number 13000201

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Injury (2348)

Event Type  malfunction  

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.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

While using mint prophy-jet prophy powder, the patient had gingiva bleeding after treatment.The patient said the powder pricks on the gingiva.No further medical treatment was required and the patient is ok now.

Manufacturer Narrative

A dhr review was conducted with no discrepancies noted.The powder is not intended to contact the patient's oral mucosa but may make accidental contact if the flow rate is not adjusted when switching between powders.

• Brand Name: PROPHY-JET PROPHY POWDER WITH SODIUM BICARBONATE
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): DENTSPLY LLC; 1301 smile way; york PA 17404
• MDR Report Key: 8213954
• MDR Text Key: 132572032
• Report Number: 2424472-2018-00211
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• PMA/PMN Number: K970342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 13000201
• Device Lot Number: 1709201
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 01/03/2019
• Supplement Dates Manufacturer Received: 01/21/2019
• Supplement Dates FDA Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1