MAUDE Adverse Event Report: CHAMPION CUSTOM BITE FLAVORED STRAPPED MOUTH GUARD

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Diarrhea (1811)

Event Date 03/09/2015

Event Type  malfunction  

Event Description

Caller purchased the above-mentioned device which helps in protecting the teeth during sports activities.As instructed by the mfr, she softened the mouth guard by soaking it in hot water.When she tried it on, she perceived a chemical taste to it.She checked through the user's manual but couldn't find any info on the chemical composition of the flavor.She would like the fda to get the mfr to include this info.So far she has had no obvious adverse reaction, though she experienced diarrhea this morning.She also insisted that this device, with its chemical taste would not be appropriate for kids' use.

• Brand Name: CUSTOM BITE FLAVORED STRAPPED MOUTH GUARD
• Type of Device: MOUTH GUARD
• Manufacturer (Section D): CHAMPION
• MDR Report Key: 4604905
• MDR Text Key: 5464727
• Report Number: MW5041443
• Device Sequence Number: 1
• Product Code: OBR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 64