WarmTouch 5030870Recalls & reported problems
Covidien LP · Upper Body Blanket · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20884521063195), received between Aug 16, 2023 and Jan 16, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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
- Contamination /Decontamination Problem1
- Device Damaged Prior to Use1
- Patient Device Interaction Problem1
Patient problems
- Burn(s)1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT A PATIENT USING A THERMAL BLANKET ON THE UPPER LIMBS, IN CONJUNCTION WITH THE WARMTOUCH HEATING EQUIPMENT, SUFFERED A THERMAL BURN ON THE RIGHT ARM. THE SURROUNDING AREA TURNED RED, AND THERE WERE TWO SPOTS, AS IF THE PATIENT'S SKIN WAS LOOSE. A SCALPEL WAS USED, AND THE AREA WAS CLEANED WITH ALCOHOLIC CHLORHEXIDINE. A CONSULTATION WITH A PLASTIC SURGEON DIAGNOSED THE INJURY AS A THERMAL BURN. THE HOSPITALIZATION WAS EXTENDED DUE TO THIS EVENT.
Patient problems: Burn(s)
MAUDE report 21167281 ↗MalfunctionAug 16, 2023Device Damaged Prior to Use; Contamination /Decontamination Problem; Device Damaged Prior to Use; Contamination /Decontamination Problem
ACCORDING TO THE REPORTER, DURING A PROCEDURE, FROM THE NOZZLE CONNECTION PORT, THE GLUED PART WAS GRADUALLY PEELING OFF, AND THE WHOLE THING INFLATED. IT REACHED TO THE STERILE AREA, WHICH INTERFERED WITH THE SURGERY. SINCE THERE WAS BLOOD AND/OR BODY FLUID ADHERENCE, THE DEVICE WAS DISPOSED OF BY THE MEDICAL INSTITUTION STAFF. THE DEVICE CAUSED DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17558280 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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