MAUDE Adverse Event Report: KERR CORPORATION NX3 TRY-IN GEL; TOOTH SHADE RESIN MATERIAL

Catalog Number 33660

Device Problem Nonstandard Device (1420)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

A doctor's office alleged that the nx3 try-in gel looked like "tipp-ex" upon extrusion.

Manufacturer Narrative

No injury was associated with this incident and the product was not used on any patients.The lot number provided was associated with a class ii recall; therefore, this report is being submitted with regard to the alleged product malfunction.Lot #4580333 has been identified as an affected lot which was part of an nx3 try-in gel recall; therefore, no further evaluations are necessary.

• Brand Name: NX3 TRY-IN GEL
• Type of Device: TOOTH SHADE RESIN MATERIAL
• Manufacturer (Section D): KERR CORPORATION; 1717 west collins ave; orange 92867
• Manufacturer (Section G): KERR CORPORATION; 1717 west collins avenue; orange 92867
• Manufacturer Contact: kerri casino ; 1717 west collins avenue; orange, CA 92867 ; 7145167634
• MDR Report Key: 3761682
• MDR Text Key: 16057224
• Report Number: 2024312-2014-00283
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• PMA/PMN Number: K001899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/29/2014

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: Dentist
• Device Expiration Date: 02/28/2014
• Device Catalogue Number: 33660
• Device Lot Number: 4580333
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/29/2014
• Initial Date FDA Received: 04/21/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/06/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other