DeRoyal 81-1020TTPRecalls & reported problems
Deroyal Industries, Inc. · TEMPLE TOUCH PRO MCU KIT · 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 00749756389198), received between Aug 20, 2025 and Aug 20, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unintended Movement” (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.
Reports received per month
Most reported problems
Device problems
- Unintended Movement1
Patient problems
- Burn(s)1
- Rash1
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 20, 2025Unintended Movement; Unintended Movement
A USER FACILITY REPORTED, "THE TEAMS PLACED THE TTP IN PREOP ON THE PATIENT'S FOREHEAD AND WHAT I CAN TELL FROM THE CHARTING, THE CRNA DID USE THE TTP (THERMOREGULATION BAND OPTION SELECTED *TEMPORAL) TO CAPTURE INTRAOP TEMPS AS WELL. IN PACU, THE TTP HAD BECOME DISLODGED AND WAS NOT GIVING CORRECT TEMPERATURES, SO THE PACU NURSE REMOVED THE TTP SENSOR TO REPOSITION IT TO RE-PLACE IT ON THE PATIENT'S FOREHEAD AREA AND NOTICED THAT THERE WERE 4 SMALL DARK SQUARES ON THE PATIENT'S SKIN THAT ALIGNED WITH THE SENSORS ON THE TTP."
Patient problems: Burn(s); Rash; Skin Inflammation/ Irritation
MAUDE report 22852952 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.