GUM® 3614 (REF RQ; RQW)Recalls & reported problems
Sunstar Americas, Inc. · PROXABRUSH GO-BETWEENS CLEANERS WIDE · Class 1
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00070942002479), received between Oct 4, 2023 and Aug 25, 2026 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Insufficient Device Problem Information1
- Loss of or Failure to Bond1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Hypersensitivity/Allergic reaction1
- Inflammation1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 25, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50441331 ↗MalfunctionDec 9, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
CONSUMER STATED THAT THE TIP OF THE PROXABRUSH CAME OFF AND SHE SWALLOWED IT. CUSTOMER WAS ASKED IF IT GOT STUCK BETWEEN THE TEETH AND CAME OFF AND SHE SAID SHE DID NOT KNOW BUT SHE IS SURE SHE SWALLOWED IT. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23760084 ↗MalfunctionNov 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
CUSTOMER USED ONE IN THE PACK AND THE BRISTLES CAME OUT IMMEDIATELY ONCE PUT IN BETWEEN THEIR TOOTH. THEY WERE ABLE TO GET ALL THE BRISTLES OUT OF THEIR MOUTH, HOWEVER THE WIRE WAS MISSING ALL THE BRISTLES WHEN USING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23493687 ↗InjuryOct 4, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
A CONSUMER HAD STATED SHE HAS NEVER USED THE INTERDENTAL PRODUCTS BEFORE. SHE HAD USED THE PROXABRUSH ON (B)(6) 2023 BEFORE SHE HAD DINNER AND SAID SHE FELT A LITTLE SOMETHING IN HER MOUTH. AFTER DINNER SHE USED THE PRODUCT AGAIN AND NOTICED SHE WAS HAVING AN ALLERGIC REACTION. HER GUMS STARTED TO TURN RED AND HAD VERY BAD BURNING FEELING. SHE SWISHED WITH BAKING SODA AND WATER AND TOOK SOME BENADRYL. SHE STILL HAS A LITTLE BURNING FEELING ON HER GUMS AFTER THE BENADRYL. SHE DID NOT SEEK MEDICAL TREATMENT. SHE IS ALLERGIC TO RUBBER.
Patient problems: Hypersensitivity/Allergic reaction; Inflammation
MAUDE report 17873023 ↗
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® 872Sunstar Americas, Inc. · TOOTHBRUSH, MANUAL3 reports
- GUM® 3612Sunstar Americas, Inc. · TOOTHBRUSH, MANUAL3 reports
- GUM® 3614Sunstar Americas, Inc. · TOOTHBRUSH, MANUAL2 reports
- GUM® 1614Sunstar 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.