GUM® 872 (REF RQ4)Recalls & reported problems
Sunstar Americas, Inc. · PROXABRUSH GO BETWEENS CLEANERS TIGHT · Class 1
All models of GUM (16)
Data updated Oct 16, 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 00070942004848), received between Dec 22, 2023 and Aug 4, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 4, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50134307 ↗MalfunctionJul 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
CUSTOMER COMPLAINED BRISTLES OF THE PROXABRUSH FELL OFF OF THE BRUSH AS SOON AS THEY STARTED USING IT, THEY RINSED OUT THEIR MOUTH OUT IMMEDIATELY AFTER AND MADE SURE THEY DIDN'T SWALLOW ANY. THERE WAS NO HARM CAUSED HOWEVER THEY WERE SCARED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22649751 ↗MalfunctionDec 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
A CONSUMER HAD PURCHASED AND IDB PROXABRUSH AND STATED THE WIRE OF THE BRUSH COMES OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18385328 ↗
Other TOOTHBRUSH, MANUAL devices
- GUM® 872Sunstar Americas, Inc. · TOOTHBRUSH, MANUAL19 reports
- GUM Technique Deep Clean 525Sunstar Americas, Inc. · Toothbrush, Manual9 reports
- GUM® 872Sunstar Americas, Inc. · TOOTHBRUSH, MANUAL8 reports
- GUM® 871Sunstar Americas, Inc. · TOOTHBRUSH, MANUAL4 reports
- GUM® 3614Sunstar Americas, Inc. · TOOTHBRUSH, MANUAL4 reports
- GUM® 3612Sunstar Americas, Inc. · TOOTHBRUSH, MANUAL3 reports
- GUM® 3612Sunstar Americas, Inc. · TOOTHBRUSH, MANUAL2 reports
- GUM® 3614Sunstar Americas, Inc. · TOOTHBRUSH, MANUAL2 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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