MAUDE Adverse Event Report: PENTRON CLINICAL FLOW-IT; TOOTH SHADE RESIN MATERIAL

Catalog Number N11B

Device Problem Air Leak (1008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

A doctor alleged that bubbles were present in flow-it composite restorations during procedures on multiple patients.

Manufacturer Narrative

Patients specifics with regard to the exact number affected, gender, age and weight were not provided by the doctor.The doctor noticed the bubbles and voids after light curing the material.The doctor removed the composite and replaced the restoration each of the patients.To date, each of the patients are doing fine.The product involved in the alleged incident was not returned and no lot number was provided; therefore, no evaluations can be conducted.

• Brand Name: FLOW-IT
• Type of Device: TOOTH SHADE RESIN MATERIAL
• Manufacturer (Section D): PENTRON CLINICAL; 1717 west collins avenue; orange CA 92867
• Manufacturer (Section G): PENTRON; 1717 west collins avenue; orange CA 92867
• Manufacturer Contact: kerri casino ; 1717 w collins ave; orange, CA 92867 ; 7145167634
• MDR Report Key: 4486640
• MDR Text Key: 17582246
• Report Number: 2024312-2015-00004
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952662
• 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: 01/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: N11B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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