MAUDE Adverse Event Report: KERR CORPORATION TEMPHASE; CROWN AND BRIDGE, TEMPORARY, RESIN

Catalog Number 28655

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Burn(s) (1757)

Event Date 03/10/2015

Event Type  Injury  

Event Description

A doctor alleged that a patient had experienced burns on their gingival after placement of the temphase material.

Manufacturer Narrative

The patient had experienced burns on the gingival tissue on areas between teeth # 31 and #41, and on tooth #36.The dentist treated the area with a medicinal ointment.To date, the patient is doing fine.An evaluation is anticipated; but has not yet begun.

Manufacturer Narrative

An appearance test, gel time test and set time test were performed on the retain sample yielding results within specification.A dhr review revealed that there were no deviations from the manufacturing process.The product was accepted and released within specifications.In addition, no similar complaints were received with regard to this lot.

• Brand Name: TEMPHASE
• Type of Device: CROWN AND BRIDGE, TEMPORARY, 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: 4665761
• MDR Text Key: 5626875
• Report Number: 2024312-2015-00008
• Device Sequence Number: 1
• Product Code: EBG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K020092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 03/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: 28655
• Device Lot Number: 5322841
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 20 YR