MalfunctionBRW
MOUTHGUARD
Received Jul 27, 2018 · Event occurred Jul 6, 2018
Report 7725929 · MDR key 7725929
Device
Product problems
- Material Puncture/Hole
Patient
14965 DA
- No Code Available
- No Code Available
Narrative
Description of Event or Problem
PATIENT UNDERWENT MICRODIRECT LARYNGOSCOPY WITH LEFT MICROFLAP EXCISION OF LEFT VOCAL CORD LESION. WHEN THE MOUTHGUARD WAS REMOVED AT THE END OF THE PROCEDURE, IT WAS FOUND TO HAVE A HOLE IN IT WHERE THE FRONT TEETH HAD MET. THE MD IS CONCERNED THAT THERE IS THE POTENTIAL FOR PIECES TO GET IN THE AIRWAY.