MAUDE Adverse Event Report: MOLNLYCKE HEALTH CARE EASYWARM; EASYWARM+ ACTIVE SELF-WARMING BLANKET

Model Number	629900-00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Partial thickness (Second Degree) Burn (2694)
Date of Event	12/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
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 has not recovered as of the last communication.

• Brand Name: EASYWARM
• Common Device Name: EASYWARM+ ACTIVE SELF-WARMING BLANKET
• Manufacturer (Section D): MOLNLYCKE HEALTH CARE; 5445 triangle parkway; peachtree corners GA 30047
• Manufacturer (Section G): COPIOUS INTERNATIONAL INC; wei 11 road huada street; heyuan, china mainland 51700 0; CH 517000
• Manufacturer Contact: rachel gill ; 5445 triangle parkway; peachtree corners, GA 30047
• MDR Report Key: 24410569
• Report Number: 3004763499-2026-00001
• Device Sequence Number: 12259116
• Product Code: DWJ
• UDI-Device Identifier: 07333350371685
• UDI-Public: 07333350371685
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K232508
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 02/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 629900-00
• Device Lot Number: 25206504
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 02/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Sex: Female