MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC THERMASEAL PLUS SEALER; RESIN, ROOT CANAL FILLING

Catalog Number TSLPLUS

Device Problems Packaging Problem (3007); Component Misassembled (4004)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

There has been a previous report received with a similar device 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 results are not available as of this report.Evaluation results will be submitted as they become available.

Event Description

It was reported that a package of thermaseal plus contained two red tubes instead of one red tube and one white tube.

Manufacturer Narrative

In the complained refill the tube b is available twice.Complaint can be confirmed.A dhr review was conducted with no discrepancies noted.The retain sample is ok.There is a tube a and a tube b available.

• Brand Name: THERMASEAL PLUS 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: 9629273
• MDR Text Key: 191103998
• Report Number: 2320721-2019-00307
• 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: 03/04/2020

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 Expiration Date: 04/30/2021
• Device Catalogue Number: TSLPLUS
• Device Lot Number: 1905001120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 01/24/2020
• Supplement Dates Manufacturer Received: 12/02/2019
• Supplement Dates FDA Received: 03/04/2020
• Patient Sequence Number: 1