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

Catalog Number 34921

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Reaction (2414)

Event Date 03/28/2014

Event Type  Injury  

Event Description

A doctor alleged that a patient had experienced an allergic reaction after placement with sonicfill composite.

Manufacturer Narrative

The doctor prescribed the patient with benadryl and asked the patient to follow-up on (b)(6) 2014; however, the patient did not show up.The doctor reported that the patient has an appointment in a few weeks.As of now, the doctor does not know what to replace the restoration with as most composite contains methylmethacrylates.To date, the doctor does not know how the patient is doing.The doctor will follow-up with regulatory affairs with any additional information.A 'visual inspection' test of the returned product was performed, 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: SONICFILL 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: 3778028
• MDR Text Key: 4437215
• Report Number: 2024312-2014-00270
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091023
• 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: 03/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 02/01/2015
• Device Catalogue Number: 34921
• Device Lot Number: 4814790
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: KETAC; FUJICEM
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 125