Barrier® EasyWarm® 629905Recalls & reported problems
Mölnlycke Health Care AB · EasyWarm, ACTIVE SELF-WARMING BLANKET, 92x152 cm · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07333350371685), received between Feb 22, 2026 and Feb 22, 2026 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Burn(s)1
- Partial thickness (Second Degree) Burn1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 22, 2026Adverse Event Without Identified Device or Use Problem
WE RECEIVED A REPORT FROM GREECE REGARDING A BURN INJURY TO A 74-YEAR-OLD PATIENT ON THE LEFT UPPER LIMB. THE PATIENT UNDERTOOK SURGERY ON (B)(6) 2025, WHICH LASTED APPROXIMATELY TWO HOURS, AND THEN REMAINED IN RECOVERY FOR ONE HOUR. THROUGHOUT THE PROCEDURE, THE PATIENT WAS COVERED FROM THE NECK DOWN WITH A CLEAN SHEET, ON TOP OF WHICH A SELF-HEATING BLANKET HAD BEEN PLACED TO PREVENT DIRECT CONTACT WITH THE SKIN. WHILE THE PATIENT WAS IN RECOVERY, THE ANESTHESIOLOGIST LIFTED THE SELF-HEATING BLANKET AND NOTICED THAT THE SHEET UNDERNEATH HAD SHIFTED FROM THE LEFT SHOULDER. AT THE POINT OF DIRECT CONTACT WITH THE BLANKET, ERYTHEMA AND A SMALL BURN WERE OBSERVED. A SOOTHING CREAM DRESSING WAS APPLIED FOR IMMEDIATE TREATMENT. ADDITIONAL INFORMATION RECEIVED 10FEB2026 INDICATED THE BURN WAS DIAGNOSED AS A PARTIAL THICKNESS BURN. PARTIAL THICKNESS BURNS ARE GENERALLY SECOND-DEGREE BURNS AND CAN BLISTER. THESE BURNS DAMAGE THE OUTER LAYER OF SKIN (EPIDERMIS) AND PART OF THE UNDERLYING LAYER (DERMIS), RESULTING IN REDNESS, SWELLING, PAIN, AND THE FORMATION OF BLISTERS. TREATMENT REPORTED INCLUDES A SOOTHING CREAM DRESSING WAS APPLIED FOR IMMEDIATE TREATMENT AND VAC PLACEMENT. THE PATIENT
Patient problems: Burn(s); Partial thickness (Second Degree) Burn
MAUDE report 24410569 ↗
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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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