GUM® 3614 (REF PQ, PQB)Recalls & reported problems
Sunstar Americas, Inc. · PROXABRUSH GO-BETWEENS CLEANERS WIDE · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00070942004909), received between Jan 3, 2025 and Jan 3, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 3, 2025Break; Break
CUSTOMER COMPLAINED ABOUT WIRE KEEPS SNAPPING DURING USE OF PROXABRUSH AND NEEDED CONSTANT REPLACING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21071769 ↗
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® 872Sunstar Americas, Inc. · TOOTHBRUSH, MANUAL3 reports
- GUM® 3612Sunstar Americas, Inc. · TOOTHBRUSH, MANUAL3 reports
- GUM® 3614Sunstar Americas, Inc. · TOOTHBRUSH, MANUAL2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.