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

Model Number N11B

Device Problems Air Leak (1008); Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

A doctor alleged that bubbles were present after placement of flow it for multiple patients.

Manufacturer Narrative

Specific patient information with regard to age and weight was not provided by the doctor.Although the doctor identified two (2) different lot numbers associated with bubbles, he could not verify which lot was used on the patient; therefore, no lot numbers were identified in this report.The lot numbers involved in the alleged incident include 5089748 and 5183433.The doctor drilled out the composite and replaced it.To date, the patients are doing fine.The products involved in the alleged incident were returned.Returned samples from the each of the reported lots were evaluated, yielding results within specifications.A dhr review indicated that there were no deviations from the manufacturing process.In addition, no similar complaints were received with regard to these lots.

• 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: 4665397
• MDR Text Key: 5626871
• Report Number: 2024312-2015-00009
• 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: 03/11/2015

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?: No
• Device Operator: Dentist
• Device Model Number: N11B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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