MAUDE Adverse Event Report: KERR CORPORATION TEMPBOND CLEAR WITH TRICLOSAN; CEMENT, DENTAL

Catalog Number 33351

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Event Description

A doctor alleged that two (2) patients had experienced a darkening of their teeth upon the removal of temporary restorations which had been placed using the tempbond clear product.This is the first of two (2) reports.

Manufacturer Narrative

Patient specifics with regard to age and weight were not provided.The doctor sandblasted and micro-etched the tooth to remove the discoloration.To date, the patient is doing fine.A visual inspection of the returned product was evaluated, 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.It was reported that the doctor used the astringedent ferric sulfate product before seating temporary restorations with the tempbond clear product.The astringedent instructions for use state: "when the tooth is not thoroughly cleaned, residual hemostatic agent or coagulum left on the tooth surface or surrounding tissue may contaminate dentin and/or enamel substrate jeopardizing the bond and seal causing microleakage.Hemosiderin from residual blood in the sulcus or in the coagulum can move between the restoration and tooth producing a dark stain on the underlying preparation.This may occur within days or weeks of placing the restoration and will require re-treatment and replacements." these investigation results indicate that the incident which had occurred was not due to a product failure.

• Brand Name: TEMPBOND CLEAR WITH TRICLOSAN
• Type of Device: CEMENT, DENTAL
• 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 ; 1717 west collins avenue; orange, CA 92867 ; 7145167634
• MDR Report Key: 3606816
• MDR Text Key: 4155024
• Report Number: 2024312-2014-00031
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K053565
• 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: 01/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 05/01/2015
• Device Catalogue Number: 33351
• Device Lot Number: 4889579
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2013
• 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: PRO TEMP; ASTRINGEDENT
• Patient Outcome(s): Other; Required Intervention