MAUDE Adverse Event Report: C B FLEET CO INC DENTEK ULTIMATE DENTAL GUARD; MOUTHGUARD

Catalog Number 10047701000400

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

Initial (20-may-2022).A 70 year old female consumer contacted the company to report that she suspected swallowing a part of a broken dentek ultimate dental guard while sleeping; she did not report any ill effects at that time.The consumer was advised to consult a doctor.Follow-up (01-jun-2022): during follow up, the consumer reported she had passed part of the guard with no complications.Meddra version 25.0.Expectedness: accidental device ingestion: unexpected device physical property issue.According to the company reference safety information.

• Brand Name: DENTEK ULTIMATE DENTAL GUARD
• Type of Device: MOUTHGUARD
• Manufacturer (Section D): C B FLEET CO INC; 4615 murray place; lynchburg VA 24502
• Manufacturer Contact: sherrie mcnamara ; 4615 murray place; lynchburg, VA 24502 ; 8889999711
• MDR Report Key: 14749151
• MDR Text Key: 294505597
• Report Number: 1719513-2022-00642
• Device Sequence Number: 1
• Product Code: OBR
• 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: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 10047701000400
• Device Lot Number: 18121
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2022
• 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
• Patient Age: 70 YR
• Patient Sex: Female