SUNMED
Received Sep 1, 2021 · Event occurred Aug 2, 2021
Report 1314417-2021-00012 · MDR key 12410355
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Tooth Fracture
- Tooth Fracture
Narrative
Additional Manufacturer Narrative
THE CUSTOMER IS MISUSING THIS ITEM. IT'S NOT INTENDED TO BE USED TO PREVENT BITING OR DAMAGE FROM A BITE. THE INTENT IS TO AID IN PROTECTING TEETH FROM EXTERNAL FORCES APPLIED DURING INTUBATION. THERE ARE NO CCS ISSUED FOR THIS DEFECT WITHIN THE LAST 2 YEARS, THE LAST AND ONLY INCIDENT IS FROM 2016. RA: THERE IS NO RMA FOR THIS PRODUCT, ONE HAS BEEN REQUESTED FROM THE REGULATORY GROUP.
Description of Event or Problem
CUSTOMER ALLEGES THAT AN "THAT WHILE USING THE MOUTH GUARD A TOOTH WAS CHIPPED."
Additional Manufacturer Narrative
A FOLLOW-UP MDR WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
Description of Event or Problem
CUSTOMER ALLEGES THAT AN "THAT WHILE USING THE MOUTH GUARD A TOOTH WAS CHIPPED."