MAUDE Adverse Event Report: KERR CORPORATION POINT 4 COMPOSITE; TOOTH SHADE RESIN MATERIAL

Catalog Number 29892

Device Problem Material Discolored (1170)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Patient information with regard to age and weight was not provided.The composite veneers were scheduled to be removed and replaced, however, the original re-treatment appointment was cancelled due to patient sickness.The dr.Indicated that an update would be provided if anything untoward occurs with the patient.The product involved in the alleged incident was evaluated, yielding results within specifications.

Event Description

A doctor alleged that a patient had experienced the yellowing of composite veneers.This is the second of two reports.

• Brand Name: POINT 4 COMPOSITE
• Type of Device: TOOTH SHADE RESIN MATERIAL
• Manufacturer (Section D): KERR CORPORATION; 1717 west collins avenue; orange CA 92867
• Manufacturer (Section G): KERR CORPORATION; 1717 west collins avenue; orange CA 92867
• Manufacturer Contact: mark dzendzel ; 1717 west collins avenue; orange, CA 92867 ; 7145167802
• MDR Report Key: 5082907
• MDR Text Key: 25991535
• Report Number: 2024312-2015-00079
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Report Date: 08/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 29892
• Device Lot Number: 5516627
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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; Required Intervention