Braun BFH125USV2Recalls & reported problems
Kaz USA, Inc. · Braun Forehead Touch therm · 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 00328785002188), received between May 18, 2020 and May 18, 2020 — 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
- Insufficient Device Problem Information1
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.
MalfunctionMay 18, 2020False Negative Result; Insufficient Device Problem Information; False Negative Result; Insufficient Device Problem Information
A CONSUMER REPORTED THAT HER THERMOMETER HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON HERSELF. THE DEVICE ALLEGEDLY GAVE READINGS THAT WERE 3.9°F LOWER THAN WHAT WAS LATER MEASURED BY THEIR DOCTOR. 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 10065241 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.