Braun IRT3030USRecalls & reported problems
Kaz USA, Inc. · Thermometer, Braun Compact Ear, Audio Fever Indicator w/21 Lens Filters. · 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 00328785000146), received between Oct 12, 2022 and Oct 12, 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
- Unspecified Kidney or Urinary Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 12, 2022False Negative Result; False Negative Result
A CONSUMER REPORTED THAT HER THERMOMETER HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON HER BABY. IT WAS STATED THAT OUR DEVICE GAVE A READING OF 98.2°F, BUT THREE HOURS LATER A DIFFERENT HOUSEHOLD THERMOMETER READ 103.0°F. THE CHILD WAS LATER TAKEN TO THE DOCTOR WHERE A FEVER AND KIDNEY INFECTION WERE CONFIRMED. IT WAS STATED THAT THE LOW READINGS GIVEN BY OUR DEVICE ALLEGEDLY MAY HAVE CAUSED A DELAY IN MEDICAL ATTENTION. THERE WERE NO COMPLICATIONS FROM THIS INCIDENT, AND THE PATIENT IS DOING WELL NOW. KAZ USA, INC. HAD REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING, BUT THE DEVICE HAS NOT YET BEEN RECEIVED.
Patient problems: Fever; Unspecified Kidney or Urinary Problem
MAUDE report 15589543 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.