Adtemp™ 413BRecalls & reported problems
American Diagnostic Corp · ADTEMP II, Dual Scale, Oral,Dig Therm, Blue, 30 sec · 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 00634782053598), received between Aug 1, 2017 and Aug 1, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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
- Device Operates Differently Than Expected1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 1, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
RECEIVED EMAILED COMPLAINT ON 7/19/2017 THROUGH OUR SALES REP AND THEN A FOLLOW-UP MEDWATCH FORM ON 7/26/2017. EMAILED COMPLAINT STATED THAT END USER FACILITY WAS HAVING AN ISSUE WITH THE MODEL 413 DIGITAL STICK THERMOMETERS. STATED ISSUES INCLUDED: THERMOMETER WON'T TURN ON. ONCE ON, CALIBRATION SET TOO HIGH AT 101-102.1 NOT THAT 98.6 THAT HAS BEEN SEEN IN THE PAST. IF IT TURNS ON, TEMPERATURE COMES UP AND WILL NOT READ PAST THAT. AUDIBLE BEEP CAN BARELY BE HEARD OR NOT AT ALL. POORLY PACKAGED-FALLING OUT OF PACKAGING VERY EASILY. THIS PACKAGING IS A PLASTIC SHEATH WITH NO CLOSURE AT TOP. NO PATIENTS WERE INVOLVED WITH THE PROBLEMS INDICATED ABOVE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6756335 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.