ALIKE™ 340591Recalls & reported problems
Gc America Inc. · ALIKE™ 4oz liquid · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI D6583405911), received between Jun 1, 2017 and Jun 1, 2017 — classified as 1 injury.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Burning Sensation1
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
GC AMERICA INC. (GCA) RECEIVED A LETTER FROM A PATIENT ON 17 MAR 2017. THE PATIENT HAD RECEIVED DENTAL WORK IN A UNIVERSITY SETTING BY A DENTAL PROVIDER ON 07 MAR 2017. THE PATIENT'S MOUTH BEGAN TO BURN. THE DENTAL PROVIDER HAD USED THE FOLLOWING CHEMICALS: VISCOSTAT, HENRY SCHEIN TEMPORARY CEMENT REMOVER, VPS TRAY ADHESIVE, AND ALIKE LIQUID MONOMER. THE DENTAL PROVIDER PUT VASELINE ON THE PATIENT'S BURNED LIPS AND GAVE THE PATIENT VASELINE TO CONTINUE PUTTING ON THEIR MOUTH. ON (B)(6) 2017, THE PATIENT HAD AN APPOINTMENT WITH THEIR PERSONAL DOCTOR TO EXAMINE THE BURNS AND TO CHECK THEIR HIGH BLOOD PRESSURE. THE PERSONAL DOCTOR PRESCRIBED CEPHALEXIN TO PREVENT AN INFECTION FROM THE BURNS AND SILVER SULFADIAZINE TO AVOID OR TREAT SKIN INFECTIONS FROM THE BURNS. NO ADDITIONAL INFORMATION WAS OBTAINED.
Patient problems: Burning Sensation; Hypersensitivity/Allergic reaction
MAUDE report 6605730 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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