WarmTouch 5030810Recalls & reported problems
Covidien LP · Full-Body /Multi Access Blanket · Class 2
All models of WarmTouch (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20884521061795), received between Dec 22, 2020 and Aug 11, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 reports).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem2
Patient problems
- Burn(s)1
- Partial thickness (Second Degree) Burn1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT THE BLANKET WAS FUNCTIONING CORRECTLY PRIOR TO AND DURING THE PROCEDURE. THE PATIENT WAS LAID ON TOP OF THE BLANKET, INSTEAD OF THE BLANKET BEING DRAPED ON TOP OF THE PATIENT. THEN THE PATIENT URINATED ONTO THE BLANKET, WHICH CAUSED BURNS ON THE PATIENT'S BUTTOCKS. THE BLANKET TEMPERATURE WAS SET TO 42 DEGREES CELSIUS HALFWAY THROUGH TO 38 DEGREES CELSIUS AND WAS WITH THE PATIENT FOR TWO HOURS AND 30 MINUTES. THERE WERE NO SIGNS OF BURNS AFTER THE PROCEDURE AND NOTICED THE FOLLOWING DAY. THE PATIENT WAS REFERRED TO PLASTICS, AND THE WOUND WAS CLEANED.
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 22771418 ↗InjuryDec 22, 2020Patient Device Interaction Problem; Patient Device Interaction Problem
ACCORDING TO THE REPORTER, THE PATIENT SUFFERED A BURN WHILE USING A BLANKET POST-OPERATIVE. IT WAS CONFIRMED THAT THERE WAS NO ABNORMALITY IN THE TESTING RELATED EQUIPMENT.
Patient problems: Burn(s)
MAUDE report 11055020 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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