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

Device Problems Patient-Device Incompatibility (2682); Material Integrity Problem (2978)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994)

Event Type  Injury  

Event Description

On (b)(6) 2014, a doctor's office had alleged that six (6) patients had experienced pain and sensitivity after placement of restorations using the herculite ultra product.This is the fourth of six (6) reports.

Manufacturer Narrative

Specific patient information such as age and weight was not provided.Although the doctor identified six (6) different lots associated with the sensitivity issues, the doctor could not verify which lot was used on any of the patients; therefore, no catalog numbers or lot numbers were identified in this report.The lots involved in the alleged incident include lot numbers 4887139 (catalog #34349), 4880077 (catalog #34776), 4444999 (catalog #34350), 4734549 (catalog #34448), and two (2) unknown lot numbers (catalog #34347 and #34348).The doctor removed and replaced the patient's restoration using a different product, without further incident.To date, the patient is doing fine.The product involved in the alleged incident was not returned.A visual and physical evaluation was performed on retained samples from the same lots for lot numbers 4887139, 4880077, and 4734549, yielding results within specifications.The lot number 4444999 was expired product; therefore, no further evaluation can be conducted.

• 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: 4306004
• MDR Text Key: 20454777
• Report Number: 2024312-2014-00674
• 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: 11/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2014
• 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: OPTIBOND SOLO PLUS
• Patient Outcome(s): Other; Required Intervention