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

Catalog Number 33351

Device Problem Failure to Disconnect (2541)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

A doctor's office alleged that temporary restorations placed with tempbond clear had to be cut off during procedures for approximately six (6) patients.This is the fifth of six (6) reports.

Manufacturer Narrative

Patient specifics with regard to gender, age, and weight were not provided.The doctor removed the patient's crown with a bur and placed the permanent restoration.To date, the patient is doing fine.A visual and physical evaluation was performed on the returned product, yielding results within specifications.In addition, no similar complaints were received with regard to this lot.

• 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 casino ; 1717 west collins avenue; orange, CA 92867 ; 7145167634
• MDR Report Key: 3579233
• MDR Text Key: 4059629
• Report Number: 2024312-2014-00019
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/19/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2014
• 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: 4861415
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2013
• 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
• Patient Outcome(s): Other; Required Intervention