GRIND NO MORE
Received Sep 5, 2024 · Event occurred Jun 29, 2024
Report 1811666-2024-00001 · MDR key 20151587
Device
Generic name
Class I
Catalog number
UNKNOWN
Lot number
UNKNOWN
Product problems
- Use of Device Problem
- Use of Device Problem
Patient
66 YR · Male
- Obstruction/Occlusion
- Choking
- Obstruction/Occlusion
- Choking
Narrative
Description of Event or Problem
SWALLOWED IN SLEEP [ACCIDENTAL DEVICE INGESTION]. CHOKED [CHOKING]. THROAT IRRITATION [THROAT IRRITATION]. CASE NARRATIVE: THIS SPONTANEOUS MEDICAL DEVICE REPORT WAS RECEIVED FROM A REPORTER ON BEHALF OF A 66-YEAR-OLD CAUCASIAN MALE WHO BEGAN USING PLACKERS GRIND NO MORE ON AN UNKNOWN DATE YEARS AGO USING ONE GUARD NIGHTLY FOR TEETH GRINDING, CHANGING TO A NEW GUARD AFTER 3 NIGHTS. ON (B)(6) 2024, THE CONSUMER ACCIDENTALLY SWALLOWED THE GUARD DURING HIS SLEEP AND CHOKED. EMERGENCY MEDICAL SERVICES WERE CALLED AND HE WAS TRANSPORTED VIA AMBULANCE TO THE EMERGENCY ROOM WHERE A CT (COMPUTED TOMOGRAPHY) SCAN OF HIS UPPER ESOPHAGUS WAS PERFORMED; RESULTS COULD NOT LOCATE THE GUARD. AN ENDOSCOPY WAS THEN PERFORMED WHICH REQUIRED IV (INTRAVENOUS) FLUID AND ANESTHESIA TO REMOVE THE GUARD FROM THE LOWER THIRD PART OF HIS ESOPHAGUS. AFTER THE PROCEDURE, HE BEGAN EXPERIENCING THROAT IRRITATION; THE REPORTER WAS UNSURE IF IT WAS FROM THE GUARD OR THE PROCEDURE. ON THE SAME DAY, REPORTED AS (B)(6) 2024, THE CONSUMER WAS SENT HOME AFTER THE PROCEDURE AND THE GUARD WAS NOT REINTRODUCED. AS OF (B)(6) 2024, THE THROAT IRRITATION CONTINUED. MEDICAL DEVICE LOT NUMBER IS UNKNOWN. MEDICAL CONFIRMATION IS BEING SOUGHT. FOLLOW UP #1: MEDICAL RECORDS PROVIDED BY REPORTER RECEIVED ON 14AUG2024 SUMMARIZE THAT THE CONSUMER WOKE UP ON (B)(6) 2024 AFTER ACCIDENTALLY SWALLOWING HIS MOUTH GUARD. HE PRESENTED TO THE EMERGENCY DEPARTMENT AND IT WAS DESCRIBED THAT HE HAD FOREIGN BODY SENSATION IN HIS THROAT. A SOFT TISSUE NECK CT (COMPUTED TOMOGRAPHY) SCAN WITHOUT CONTRAST WAS PERFORMED WHICH DID NOT SHOW ANY FOREIGN BODY. ON (B)(6) 2024, AN ENDOSCOPY WAS PREFORMED IN THE OR (OPERATING ROOM) UNDER GENERAL ANESTHESIA WITH ENDOTRACHEAL INTUBATION. THE GUARD WAS FOUND IN THE LOWER THIRD OF HIS ESOPHAGUS AND REMOVAL WAS ACCOMPLISHED WITH RAT-TOOTHED FORCEPS. FURTHER EXAMINATION OF THE ESOPHAGUS WAS DESCRIBED AS NORMAL. ON (B)(6) 2024, HE WAS DISCHARGED ON THE SAME DAY WITH INSTRUCTION THAT NO ADDITIONAL TREATMENT WAS NEEDED.
Description of Event or Problem
SWALLOWED IN SLEEP [ACCIDENTAL DEVICE INGESTION]. CHOKED [CHOKING]. THROAT IRRITATION [THROAT IRRITATION]. CASE NARRATIVE: THIS SPONTANEOUS MEDICAL DEVICE REPORT WAS RECEIVED FROM A REPORTER ON BEHALF OF A 66-YEAR-OLD CAUCASIAN MALE WHO BEGAN USING PLACKERS GRIND NO MORE ON AN UNKNOWN DATE YEARS AGO USING ONE GUARD NIGHTLY FOR TEETH GRINDING, CHANGING TO A NEW GUARD AFTER 3 NIGHTS. ON (B)(6) 2024, THE CONSUMER ACCIDENTALLY SWALLOWED THE GUARD DURING HIS SLEEP AND CHOKED. EMERGENCY MEDICAL SERVICES WERE CALLED AND HE WAS TRANSPORTED VIA AMBULANCE TO THE EMERGENCY ROOM WHERE A CT (COMPUTED TOMOGRAPHY) SCAN OF HIS UPPER ESOPHAGUS WAS PERFORMED; RESULTS COULD NOT LOCATE THE GUARD. AN ENDOSCOPY WAS THEN PERFORMED WHICH REQUIRED IV (INTRAVENOUS) FLUID AND ANESTHESIA TO REMOVE THE GUARD FROM THE LOWER THIRD PART OF HIS ESOPHAGUS. AFTER THE PROCEDURE, HE BEGAN EXPERIENCING THROAT IRRITATION; THE REPORTER WAS UNSURE IF IT WAS FROM THE GUARD OR THE PROCEDURE. ON THE SAME DAY, REPORTED AS (B)(6) 2024, THE CONSUMER WAS SENT HOME AFTER THE PROCEDURE AND THE GUARD WAS NOT REINTRODUCED. AS OF (B)(6) 2024, THE THROAT IRRITATION CONTINUED. MEDICAL DEVICE LOT NUMBER IS UNKNOWN. MEDICAL CONFIRMATION IS BEING SOUGHT.