MAUDE Adverse Event Report: KERR CORPORATION OPTIBOND SOLO PLUS; RESIN TOOTH BONDING AGENT

Catalog Number 35106

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Sensitivity of Teeth (2427)

Event Type  Injury  

Event Description

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

Manufacturer Narrative

Specific patient information such as age and weight was not provided.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 evaluation was performed on a retained sample from the same lot, yielding results within specifications.

• Brand Name: OPTIBOND SOLO PLUS
• Type of Device: RESIN TOOTH BONDING AGENT
• 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: 4306078
• MDR Text Key: 5085368
• Report Number: 2024312-2014-00680
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991808
• 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
• Device Expiration Date: 02/01/2016
• Device Catalogue Number: 35106
• Device Lot Number: 5136177
• 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
• Date Device Manufactured: 03/31/2014
• 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
• Treatment: HERCULITE ULTRA
• Patient Outcome(s): Other; Required Intervention