MAUDE Adverse Event Report: KERR CORPORATION HERCULITE ULTRA; MATERIAL, TOOTH SHADE, RESIN

Catalog Number 34348

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 10/01/2014

Event Type  Injury  

Event Description

A doctor alleged that the herculite ultra composite did not fully polymerize during a patient procedure.

Manufacturer Narrative

The doctor scooped out and drilled out the remainder composite.The doctor completed the procedure using a different product, without further incident.To date, the patient is doing fine.The product alleged in this incident was not returned; therefore, a 'depth of cure' and 'curing test per tip' tests were performed, yielding results within specifications.A dhr review revealed that there were no deviations within the manufacturing process.In addition, no similar complaints were received with regard to this lot.

• Brand Name: HERCULITE ULTRA
• Type of Device: MATERIAL, TOOTH SHADE, RESIN
• 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: 4210674
• MDR Text Key: 21834981
• Report Number: 2024312-2014-00654
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082671
• 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: 10/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 05/01/2017
• Device Catalogue Number: 34348
• Device Lot Number: 5184294
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2014
• 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
• Patient Age: 50 YR
• Patient Weight: 61