GUM® 872 (REF PQ, PQB)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
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00070942752862), received between Oct 28, 2024 and Sep 22, 2026 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Break” (5 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
- Break5
- Detachment of Device or Device Component3
Patient problems
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Break
CONSUMER WAS WEDGING THE BRUSH IN BETWEEN HER TEETH IN THE BOTTOM QUADRANT IN THE FRONT AND IT BROKE OFF THE BRUSH WAS STUCK IN BETWEEN HER TEETH. IT WAS STUCK BETWEEN 22 AND 23. CONSUMER PUSHED THE BROKEN BRUSH OUT WITH HER FINGERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50856473 ↗MalfunctionFeb 24, 2026Break
SHE HAS BEEN USING THE 872'S AND THEY ARE BREAKING FROM THE HANDLE AFTER A FEW USES. SHE DOES NOT HAVE THE BROKEN ONES TO SEND BACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24434376 ↗MalfunctionSep 10, 2025Break; Break
CUSTOMER BOUGHT GUM® PROXABRUSH® GO-BETWEENS® TIGHT AND STATED THE EACH OF THE TEN PICKS BROKE OFF IN HIS MOUTH AFTER MINIMAL USAGE: MORE THAN ONE DURING INITIAL USE. CUSTOMER STATED HE DID NOT SUSTAIN ANY INJURY FROM THE PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23019772 ↗MalfunctionAug 5, 2025Break; Break
CUSTOMER WAS USING THE TIGHT PROXABRUSH AFTER DINNER AND THE BRUSH END BROKE OFF DURING USE AND CUSTOMER ACCIDENTALLY SWALLOWED IT, CUSTOMER SAID THEY THINK THEY BENT THE BRUSH AT THE WIRE BY MISTAKE BEFORE HAND, CUSTOMER WAS FEELING OK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22719780 ↗MalfunctionMay 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
CUSTOMER COMPLAINED BRISTLES STARTED FALLING OFF THE BRUSH RIGHT OUT OF THE PACKAGE, HE GRABBED ONE OUT OF THE PACK TO TEST THEM AFTER THIS AND HE SAID HE JUST GENTLY RUBBED THEM WITH HIS FINGERS AND BRISTLES IMMEDIATELY STARTED FALLING. THEY ALSO SAID METAL WIRE FROM THE TIP TO THE RUBBER HANDLE BARELY HAD ANY BRISTLE AND THE BRISTLES SEEMED VERY FINE (LIKE MORE SO THAN USUAL).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22006840 ↗MalfunctionFeb 18, 2025Break; Break
CUSTOMER COMPLAINED WIRE KEPT BENDING AND BREAKING DURING USAGE DURING ONE SESSION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21405341 ↗MalfunctionNov 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
CUSTOMER BOUGHT PROXABRUSH GO BETWEEN CLEANERS, COMPLAINED ABOUT MISSING METAL AND BREAKING BEFORE USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20700408 ↗MalfunctionOct 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
CUSTOMER PURCHASED GUM PROXABRUSH GO-BETWEENS CLEANERS AND, MENTIONED BRISTLES IMMEDIATELY CAME OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20543639 ↗
Other TOOTHBRUSH, MANUAL devices
- GUM® 872Sunstar Americas, Inc. · TOOTHBRUSH, MANUAL19 reports
- GUM Technique Deep Clean 525Sunstar Americas, Inc. · Toothbrush, Manual9 reports
- GUM® 871Sunstar Americas, Inc. · TOOTHBRUSH, MANUAL4 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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