Plackers-Grind No More 78500 82744Recalls & reported problems
Ranir, LLC · Grind No More Disposable Dental Guards Up to 30 Uses 10ct. QWL46 · Class U
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00651080651516), received between Dec 31, 2020 and Oct 12, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Component Missing” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Component Missing1
- Entrapment of Device1
- Patient-Device Incompatibility1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 12, 2021Patient-Device Incompatibility
I KNOW THE BOX SAYS ONE SIZE FITS ALL, BUT I WENT TO SLEEP WITH ONE IN AND WOKE UP WITH IT IN THE BACK OF MY THROAT, MY WIFE PULLED IT OUT AND I TRIED IT AGAIN. WHEN I WOKE UP THE SECOND TIME I COULD FEEL IT IN MY THROAT, I SWALLOWED IT AGAIN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12614712 ↗MalfunctionMar 11, 2021Component Missing
CONSUMER STATED: I¿VE BEEN USING THESE FOR ABOUT A WEEK. I WOKE UP THIS MORNING, AND THE GUARD WAS MISSING. I CHECKED ALL AROUND AND UNDER THE BED. NO GUARD. I¿M GUESSING I SWALLOWED IT WHILE I WAS ASLEEP. CONSUMER DIDN'T RESPOND WHETHER OR NOT HE FOUND THE GUARD IN HIS BED.
Patient problems: Insufficient Information
MAUDE report 11464159 ↗MalfunctionDec 31, 2020Entrapment of Device
CONSUMER STATED SHE HAS BEEN USING PLACKERS NIGHT GUARDS FOR AT LEAST 5 MONTHS. SHE SAID SHE SWALLOWED IT. WHEN SHE WOKE UP, IT WASN¿T IN HER MOUTH ANY MORE. IT¿S NEVER HAPPENED BEFORE. SHE HAS NO DISCOMFORT OR FEELING THAT IT IS IN HER THROAT. INFORMED CONSUMER TO LET US KNOW IF THE GUARD WAS FOUND LATER IN HER BED.
Patient problems: Foreign Body In Patient
MAUDE report 11101436 ↗
Other Mouthguard, Over-The-Counter devices
- Plackers 78501Ranir, LLC · Mouthguard, Over-The-Counter2 reports
- Equate SQNWal-Mart Stores, Inc. · Mouthguard, Over-The-Counter1 report
- Meijer SQNMeijer, Inc. · Mouthguard, Over-The-Counter1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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