KEYSPLINT SOFT

Description of Event or Problem

PATIENT REPORTED TRYING KEYSPLINT SOFT APPLIANCE AND WAKING UP IN THE MORNING WITH A MOUTH FULL OF SORES THE SORES TURNED INTO MUCOSITIS THAT WAS SUPER PAINFUL. PATIENT WENT TO THE EMERGENCY ROOM 4 TIMES, TO GET PAIN RELIEF AND SPECIAL MOUTHWASH DESIGNED FOR CANCER PATIENTS. PATIENT REPORTS GOING ON AN IV DRIP BECAUSE OF DEHYDRATION FROM NOT BEING ABLE TO EAT OR DRINK.

Additional Manufacturer Narrative

ON (B)(6) 2024, KEYSTONE INDUSTRIES WAS NOTIFIED BY A PATIENT OF AN ADVERSE EVENT INVOLVING ONE OR MORE DEVICES MANUFACTURED FROM THE COMPANY'S 3D KEYPRINT RESIN PRODUCTS. THE PATIENT INITIALLY CONTACTED IMAGINE DENTAL, A DENTAL OFFICE LOCATED IN CALGARY, ALBERTA, CANADA, WHICH SUBSEQUENTLY FORWARDED THE REPORT TO KEYSTONE INDUSTRIES. THE PATIENT ALSO REPORTED HAVING A SEPARATE REACTION TO ANOTHER SIMILAR DEVICE, KEYSPLINT HARD, WHICH INCLUDED SWELLING OF THE MOUTH, THROAT AND UPPER LIP. REFERENCE 3010002722-2025-00003. BOTH EVENTS OCCURRED IN CANADA AND WERE PREVIOUSLY REPORTED TO HEALTH CANADA ON (B)(6) 2024. THE ADVERSE EVENT INVOLVING THE KEYSPLINT SOFT DEVICE IS NOW BEING REPORTED TO THE FDA RETROACTIVELY, FOLLOWING CLARIFICATION OF FDA REQUIREMENTS FOR REPORTING ADVERSE EVENTS OCCURRING OUTSIDE OF THE UNITED STATES.