Chewies ™ AC-GMRecalls & reported problems
Dentsply Sirona Orthodontics Inc. · Chewies (TM) Aligner Tray Seaters - 10pk Green Mint · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI D746ACGM1), received between Jul 24, 2024 and Jul 24, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Patient-Device Incompatibility1
Patient problems
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 24, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED THAT AC-GM ESSIX ALIGNER CHEWIE GREEN MINT 20PK THAT A PATIENT USED CAUSED AN ALLERGIC REACTION. THE PATIENT EXPERIENCED THROAT AND FACE SWELLING. THE PATIENT WAS HOSPITALIZED AND TREATED FOR ANAPHYLAXIS AND GIVEN STEROIDS OVERNIGHT. THEY WERE DISCHARGED THE FOLLOWING DAY, THE DOCTORS ADVISED THE PATIENT THEIR ANAPHYLAXIS WAS CAUSED BY THE CHEWIES AND TO CEASE USE. PATIENT HAD NO KNOWN ALLERGIES PRIOR TO THIS EVENT.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 19816018 ↗
Other PUSHER, BAND, ORTHODONTIC devices
- Chewies ™ AC150PBGDSDentsply Sirona Orthodontics Inc. · PUSHER, BAND, ORTHODONTIC1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.