MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC DUAL CHAMBER SYRINGE SEALER; RESIN, ROOT CANAL FILLING

Catalog Number RIBBON

Device Problems Excess Flow or Over-Infusion (1311); Material Protrusion/Extrusion (2979)

Patient Problems Numbness (2415); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

There has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr 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

In this event it was reported that during placement of a waveone gold obturator, sealer extruded out past the apex.The patient experienced numbness.

Manufacturer Narrative

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

• Brand Name: DUAL CHAMBER SYRINGE SEALER
• Type of Device: RESIN, ROOT CANAL FILLING
• Manufacturer (Section D): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• MDR Report Key: 9204588
• MDR Text Key: 191037651
• Report Number: 2320721-2019-00211
• Device Sequence Number: 1
• Product Code: KIF
• Combination Product (y/n): N
• PMA/PMN Number: K960548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

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: RIBBON
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/17/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/15/2020
• Patient Sequence Number: 1