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

Catalog Number 32650

Device Problems Material Discolored (1170); Material Integrity Problem (2978)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

A doctor alleged that two (2) patients had experienced graying at the margins after placement with premise.This is the second of two (2) reports.

Manufacturer Narrative

It was reported that the doctor replaced the restoration for the patient.To date, the patient is doing fine.The product was not returned and no lot number was provided; therefore, no further evaluations can be conducted.

• Brand Name: PREMISE 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: kerri casino ; 1717 west collins avenue; orange, CA 92867 ; 7145167634
• MDR Report Key: 4847166
• MDR Text Key: 5807067
• Report Number: 2024312-2015-00027
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032921
• 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: 05/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 32650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: G-BOND; GRADIA FLOWABLE
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 68