Vicks V912BBUSV1Recalls & reported problems
Kaz USA, Inc. · Thermometer, Baby packaging version of V912USV1, 8 sec, SpeedRead · Class 2
- 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 00328785000481), received between Dec 8, 2022 and Dec 8, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “False Negative Result” (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.
Most reported problems
Device problems
- False Negative Result1
Patient problems
- Fever1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 8, 2022False Negative Result; False Negative Result
A CONSUMER REPORTED THAT HER THERMOMETER HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON HER INFANT. THE DEVICE ALLEGEDLY GAVE A READING OF 94.4°F, AND A FEVER OF 101.1°F WAS LATER CONFIRMED BY THEIR PEDIATRICIAN. THERE WERE NO COMPLICATIONS FROM THIS INCIDENT, AND THE PATIENT IS DOING WELL NOW. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.
Patient problems: Fever
MAUDE report 15939654 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.