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

Catalog Number RIBBON

Device Problem Overfill (2404)

Patient Problems Pain (1994); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Because this event resulted in a serious injury, it is reportable per 21cfr part 803.Retain product was tested and found to be within specification.A dhr review was conducted with no discrepancies noted.

Event Description

It was reported that a dentist overfilled a patient's root canal with dual chamber syringe sealer.The patient had pain so the dentist extracted the patient's tooth.

• 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
• Manufacturer (Section G): DENTSPLY DETREY GMBH; detrey strasse 1; konstanz, 78467 ; GM 78467
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 7440087
• MDR Text Key: 105804417
• Report Number: 2320721-2018-00020
• Device Sequence Number: 1
• Product Code: KIF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960548
• 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: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: RIBBON
• Device Lot Number: 1611000644
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability