MAUDE Adverse Event Report: PENTRON CLINICAL CORRECT PLUS THICK N' THIN; IMPRESSION MATERIAL

Catalog Number Q34GC

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

A doctor alleged that the correct plus thick n'thin material was setting too quickly which had caused crowns to come back that either required adjustment or do not fit at all on multiple patients.

Manufacturer Narrative

Specific information with regard to the number of patients affected, genders, ages, or weights were not provided by the doctor's office.The doctor's office reported that six (6) crowns either had to be sent back to the lab for adjustments or the patients had to return to the office to take a new impression and have the crowns re-made.To date, each of the patients is doing fine.A 'working time' and 'oral set time' tests 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.

• Brand Name: CORRECT PLUS THICK N' THIN
• Type of Device: IMPRESSION MATERIAL
• Manufacturer (Section D): PENTRON CLINICAL; 1717 west collins avenue; orange CA 92867
• Manufacturer (Section G): KERR CORPORATION; 1717 west collins avenue; orange CA 92867
• Manufacturer Contact: kerri casino ; 1717 w collins ave; orange, CA 92867 ; 7145167634
• MDR Report Key: 3602093
• MDR Text Key: 18858172
• Report Number: 2024312-2014-00021
• Device Sequence Number: 1
• Product Code: ELW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001218
• 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: 01/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 02/01/2016
• Device Catalogue Number: Q34GC
• Device Lot Number: 4810481
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2013
• 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