INVISALIGN CLEANING CRYSTALS
Received Apr 1, 2025 · Event occurred Feb 19, 2025
Report 2953749-2025-00621 · MDR key 21740625
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
19 YR · Female
- Burning Sensation
- Numbness
- Aphonia
- Burning Sensation
- Numbness
- Aphonia
Narrative
Additional Manufacturer Narrative
INFORMATION WAS EDITED: THE BRAND NAME AND LABELED FOR USE WERE MODIFIED.
Additional Manufacturer Narrative
THE CURRENT INDICATIONS FOR USE (IFU) CONTAINS THE FOLLOWING: "WARNINGS - DO NOT PLACE CRYSTALS IN MOUTH OR INGEST. IN CASE OF ACCIDENTAL INGESTION, IMMEDIATELY CONTACT A POISON-CONTROL CENTER.". NO CONCLUSIVE EVIDENCE HAS BEEN PROVIDED THAT SUPPORTS OR OPPOSES WHETHER THE CLEANING CRYSTALS, PACKETTE CAUSED OR CONTRIBUTED TO THE REQUIRED HOSPITALIZATION (INITIAL OR PROLONGED) AND THE CLEANING CRYSTALS, PACKETTE WERE BEING USED. THEREFORE, AN MDR WILL BE FILED IN THE UNITED STATES PER 21 CFR 803.
Description of Event or Problem
THE TREATED PATIENT REPORTED PERSISTENT DIFFICULTY CLOSING THE MOUTH, NUMBNESS, TINGLING, AND BURNING IN THE MOUTH AFTER USING THE CLEANING CRYSTALS, THAT HAVE IMPACTED THE ABILITY TO SPEAK, EAT SWALLOW AND WEIGHT LOSS THAT REQUIRED HOSPITALIZATION FOR 4 DAYS ON (B)(6). THESE SYMPTOMS DO NOT APPEAR TO BE LIFE THREATENING TO THE PATIENT. THE PATIENT INDICATED THAT DURING THE HOSPITALIZATION, REQUIRED DIFFERENT MEDICATIONS (NOT CLARIFIED HOW MANY OR WHICH ONES) TO ALLEVIATE THE REPORTED SYMPTOM(S). NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.