MAUDE Adverse Event Report: C B FLEET CO INC DENTEK TEMPARIN TEMPORARY REPAIR 1.1 G; ZINC OXIDE EUGENOL

Catalog Number 00024102406B

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Tooth Fracture (2428)

Event Type  Injury  

Event Description

Initial ((b)(6) 2022): this serious case received via email refers to a male consumer whose concomitant medication, allergies, and medical history were not reported.The consumer used the dentek temparin max repair kit for 3 days for an unknown indication and reported loss of his front teeth.This case outcome is unknown.Meddra version (b)(4).Expectedness: tooth loss: unexpected.Device use issue.According to the company reference safety information.

• Brand Name: DENTEK TEMPARIN TEMPORARY REPAIR 1.1 G
• Type of Device: ZINC OXIDE EUGENOL
• Manufacturer (Section D): C B FLEET CO INC; 4615 murray place; lynchburg VA 24502
• MDR Report Key: 14524899
• MDR Text Key: 294785946
• Report Number: 1719513-2022-00482
• Device Sequence Number: 1
• Product Code: EMB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 00024102406B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/24/2022
• Initial Date FDA Received: 05/27/2022
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Sex: Male