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Publix 2G4Recalls & reported problems

Publix Super Markets, Inc. · PKFL MM II 150 · Class 1

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00651080186513), received between Apr 6, 2021 and Oct 5, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Slipped” (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

  • Device Slipped1
  • Human-Device Interface Problem1

Patient problems

  • Insufficient Information1
  • Tooth Fracture1

Recent adverse event reports

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

  • InjuryOct 5, 2021Device Slipped

    CONSUMER STATED: LAST NIGHT I WAS FLOSSING MY TEETH BEFORE BED AND MY CROWN ON MY UPPER RIGHT HAND SIDE CAME FLYING OUT. UNFORTUNATELY I HAVE TO WAIT UNTIL MY DENTIST OFFICE OPENS FOR THEM TO ACCESS THE DAMAGE. CONSUMER EMAIL RESPONSE: TOP RIGHT HAND SIDE MOLAR. CROWN POPPED OFF AS I WAS FLOSSING. ALSO, I THOUGHT I SHOULD MENTION THAT I JUST HAD MY ROUTINE 6 MONTH DENTAL EXAM RECENTLY AND THE DENTIST FOUND NOTHING WRONG WITH MY CROWN.

    Patient problems: Insufficient Information

    MAUDE report 12579467 ↗
  • MalfunctionApr 6, 2021Human-Device Interface Problem

    CONSUMER STATED: "I AM USING YOUR DENTAL FLOSSERS ALREADY FOR FER MONTHS. JUST FINISHED INSTALLING A CROWN FOR A TOOTH WHICH BROKE OFF AFTER USING YOUR FLOSSERS. AFTER IT BROKE OFF, THOUGHT THAT'S MY TOOTH WAS BROKEN, BUT AFTER INSTALLING A CROWN MY DENTIST CHECKED MY TEETH WITH X-RAY AND DID NOT FIND ANY ADDITIONAL PROBLEMS. NOW THE INTERESTING PART STARTS! WHILE USING YOUR FLOSSERS, MY SECOND TOOTH BROKE OFF. AND IT IS HUGE ONE. I AM SENDING YOU PICTURES OF THE BROKEN TOOTH AND A PACKAGE PICTURE. TOMORROW I WILL GO TO MY DENTIST FOR HIS PROFESSIONAL OPINION AND IF HE WILL CONFIRM THAT TOOTH WAS NOT CRACKED, I AM FILING A LAWSUIT." NO PRODUCT RETURNED.

    Patient problems: Tooth Fracture

    MAUDE report 11623052 ↗

Other Floss, Dental devices

All Floss, Dental devices →

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