MAUDE Adverse Event Report: C B FLEET CO INC DENTEK TEMPARIN TEMPORARY REPAIR 2.64G; ZINC OXIDE EUGENOL

Catalog Number 00012303606G

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Initial ((b)(6) 2022): this serious case reported via telephone refers to a female consumer whose age, medical history, allergies were not reported.The consumer used a dentek temparin temporary repair kit for over a year to repair a broken tooth.Subsequently, the consumer reported developing numbness in her cheek, pulsating pain, infection and abscess; then reported she went to the dentist had to have the tooth removed.She reported taking tylenol for the pain and was prescribed antibiotics after the extraction.The consumer reported she is fine now.This case outcome is recovered/resolved.Meddra version 25.0.Expectedness: hypoaesthesia oral: unexpected.Pain: unexpected.Infection: unexpected.Abscess oral: unexpected.Tooth loss: unexpected.Device use issue.According to the company reference safety information.

• Brand Name: DENTEK TEMPARIN TEMPORARY REPAIR 2.64G
• Type of Device: ZINC OXIDE EUGENOL
• Manufacturer (Section D): C B FLEET CO INC; 4615 murray place; lynchburg VA 24502
• MDR Report Key: 14524702
• MDR Text Key: 292959384
• Report Number: 1719513-2022-00312
• 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

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 00012303606G
• Device Lot Number: 2101ZZZK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/10/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Female