Equate SQNRecalls & reported problems
Wal-Mart Stores, Inc. · Rest Assured Mouth Guard with Tray · Class U
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00681131135603), received between May 4, 2020 and May 4, 2020 — classified as 1 malfunction.
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.
Most reported problems
Device problems
- Patient-Device Incompatibility1
Patient problems
- Pain1
- Reaction1
- Swelling1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 4, 2020Patient-Device Incompatibility
THE CONSUMER EXPLAINED THAT AFTER 10 DAYS, SHE WAS AWAKENED BY "PAINS HER MOUTH AND IMMEDIATELY REMOVED THE PROTECTOR. WHEN SHE AWOKE THE NEXT MORNING, ONE SIDE OF HER FACE WAS SWOLLEN. I OBVIOUSLY HAD A REACTION TO WEARING THE PROTECTOR. THE SWELLING EASED AFTER ICE PACKS AND A WEEK OF MILD INFLAMMATORY TABLETS.
Patient problems: Pain; Reaction; Swelling
MAUDE report 10022062 ↗
Other Mouthguard, Over-The-Counter devices
- Plackers-Grind No More 78500 82744Ranir, LLC · Mouthguard, Over-The-Counter3 reports
- Plackers 78501Ranir, LLC · Mouthguard, Over-The-Counter2 reports
- Meijer SQNMeijer, Inc. · Mouthguard, Over-The-Counter1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.