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Plackers 78501Recalls & reported problems

Ranir, LLC · GRIND NO MORE 16 DENTAL GUARDS UP TO 48 USES QWL73 · Class U

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00651080651523), received between Apr 13, 2020 and Jul 22, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (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

  • Adverse Event Without Identified Device or Use Problem1
  • Product Quality Problem1

Patient problems

  • Choking1
  • Discomfort1
  • Pain1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 22, 2021Product Quality Problem

    REVIEW POSTED ON (B)(6): SO DISAPPOINTED. ROLLS IN YOU MOUTH. VERY DIFFICULT TO KEEP IN PLACE. NOT FAIR TO RECEIVE A BAD PRODUCT THAT YOU MUST KEEP. AT NIGHT THEY SLIDE AROUND SO MUCH IT WAKES YOU AND THE SECOND NIGHT I WOKE UP CHOKING ON IT. POORLY MADE PRODUCT. NO PRODUCT RETURNED, NO CONTACT INFO.

    Patient problems: Choking

    MAUDE report 12214369 ↗
  • MalfunctionApr 13, 2020Adverse Event Without Identified Device or Use Problem

    CONSUMER STATED: "THESE WERE EASY TO USE, NO FITTING OR BOILING INVOLVED. YOU DO NEED TO ONLY USE THEM FOR 3 OR 4 DAYS, BECAUSE THEY QUICKLY BECOME TOO FLEXIBLE TO STAY WHERE YOU WANT THEM. HOWEVER, MY BIGGEST PROBLEM IS THAT OVER THE COURSE OF A FEW MONTHS (SIX MAYBE?) MY TEETH SLOWLY REALIGNED THEMSELVES, AND I WAS LEFT WITH TOOTH PAIN FROM UNEVEN PRESSURE POINTS ON THE BACK OF MY JAW. MY MOLARS JUST SORT OF REALIGNED, AND THEN THERE WAS DISCOMFORT THAT JUST GOT WORSE AND WORSE OVER A COUPLE WEEKS. A TRIP TO THE DENTIST, SOME EDGE GRINDING TO REMOVE THE PRESSURE POINTS, AND IT'S STILL TAKING TIME TO RECOVER FROM THIS." NO CONTACT INFORMATION PROVIDED, UNABLE TO RETRIEVE PRODUCT OR ASK FOR FURTHER INFO.

    Patient problems: Discomfort; Pain

    MAUDE report 9954161 ↗

Other Mouthguard, Over-The-Counter devices

All Mouthguard, Over-The-Counter devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.