MAUDE Adverse Event Report: KERR CORPORATION BUILD IT FR; TOOTH SHADE RESIN MATERIAL

Catalog Number N32FE

Device Problem Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

A doctor alleged that the build it fr material was too runny during a patient procedure.

Manufacturer Narrative

Specific patient information with regard to age, gender, and weight was not provided.It was reported that the doctor had to re-do the restoration for tooth #3 for the patient using a different product, without further incident.To date, the patient is doing fine.An 'appearance,' 'gel set time,' and 'set time' test were performed on the returned product, yielding results within specifications.A dhr review revealed that there were no deviations from the manufacturing process.In addition, no similar complaints were received with regard to this lot.

• Brand Name: BUILD IT FR
• 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: 4301148
• MDR Text Key: 19762683
• Report Number: 2024312-2014-00678
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K994359
• 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: 11/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 04/30/2016
• Device Catalogue Number: N32FE
• Device Lot Number: 5233769
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2014
• 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