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

Catalog Number 10047701000400

Device Problem No Apparent Adverse Event (3189)

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

Event Type  Injury  

Event Description

Initial (06-may-2022).A male consumer contacted the company to report that he suspected swallowing a dentek ultimate dental guard while wearing a cpap machine; he did not report any ill effects at that time.The consumer was advised to consult a doctor.Follow-up (16-may-2022): during follow up, the consumer reported he had called a doctor who advised he be examined to ensure the guard was not located in the lung.It was confirmed the guard was in the small intestine which was later passed in his stool; there were no ill effects at that time either.Meddra version 25.0.Expectedness:.Accidental device ingestion: unexpected.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: 14635378
• MDR Text Key: 294850328
• Report Number: 1719513-2022-00508
• 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: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 10047701000400
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/16/2022
• 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 Sex: Male