GUM® 871 (REF RQ; RQW)Recalls & reported problems
Sunstar Americas, Inc. · PROXABRUSH GO-BETWEENS CLEANERS ULTRA TIGHT · Class 1
All models of GUM (16)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00070942002431), received between Nov 6, 2023 and Feb 3, 2026 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
- Detachment of Device or Device Component1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Pain1
- Tooth Fracture1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryFeb 3, 2026Use of Device Problem
DENTAL DAMAGE CAUSED BY PRODUCT HELLO, I AM CONTACTING YOU REGARDING MY PURCHASE OF GUM PROXABRUSH GO-BETWEENS ¿ ULTRA TIGHT (ORDER ID: (B)(4). DESPITE BEING ADVERTISED AS SOFT AND SAFE FOR GUM HEALTH, THESE INTERDENTAL BRUSHES WERE EXTREMELY HARD AND RIGID WHEN USED. DURING NORMAL USE, THE EXCESSIVE HARDNESS CAUSED DAMAGE TO MY TOOTH, RESULTING IN A CHIPPED TOOTH TIP. THIS IS COMPLETELY UNACCEPTABLE FOR A DENTAL CARE PRODUCT. ADDITIONALLY, THE BRUSHES SHOWED POOR CONSTRUCTION AND INSTABILITY, MAKING THEM UNSAFE FOR ORAL USE. A PRODUCT INTENDED FOR ULTRA-TIGHT SPACES SHOULD BE GENTLE AND CONTROLLED, NOT STRONG ENOUGH TO CAUSE PHYSICAL DENTAL DAMAGE. THIS PRODUCT IS CLEARLY NOT AS DESCRIBED AND REPRESENTS A SERIOUS SAFETY ISSUE.
Patient problems: Tooth Fracture
MAUDE report 24252418 ↗InjuryOct 27, 2025Break; Break
CUSTOMER USED IDB AND IT BROKE OFF IN BETWEEN HER TEETH. ALTHOUGH THERE WAS NO DAMAGE TO PERMANENT STRUCTURE, CUSTOMER DID VISIT TO URGENT CARE TO REMOVE BROKEN PIECE OF IDB. HER JAW IS SORE FROM HAVING HER JAW OPEN FOR A LONG AMOUNT OF TIME.
Patient problems: Pain
MAUDE report 23390853 ↗MalfunctionSep 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
WAS USING 871RQ AND THE TIP BROKE AND STUCK BETWEEN TEETH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20302678 ↗MalfunctionNov 6, 2023Break; Break
CUSTOMER PURCHASED ONE OF THE ULTRA TIGHT PROXABRUSH IDB'S AND SAID THE BRUSH IS BREAKING OFF THE WIRE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18073211 ↗
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® 3614Sunstar Americas, Inc. · TOOTHBRUSH, MANUAL4 reports
- GUM® 3612Sunstar Americas, Inc. · TOOTHBRUSH, MANUAL3 reports
- GUM® 872Sunstar 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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