Level 1 SWU-2113Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10610586043475), received between Apr 27, 2017 and Jan 10, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT AFTER THE USE OF THE PRODUCT, THE CUSTOMER NOTICED THAT THE PATIENT HAD SPOTS ON HIS (OR HER) SKIN ALONG THE HOLES IN THE BLANKET. THE CUSTOMER SUSPECTS THIS EVENT MAY HAVE BEEN A LOW-TEMPERATURE BURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16129854 ↗
• InjurySep 23, 2021Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT AFTER USE WITH THE PRODUCT WAS DONE, A BURN WAS NOTICED ON THE PATIENT. THE BURN WAS ABOUT 18CM OF THE ARMPIT. THIS WAS FOUND WHEN IT WAS NOTICED THAT THE PRODUCT WAS STUCK TO THE PATIENT IN THE BURNED AREA. THE SET TEMPERATURE OF THE PRODUCT DURING USE WAS 40?. AND IN THE LAST 20 MINUTES OF USE, IT WAS SET AT 44?. THE PATIENT WAS MEDICALLY TREATED.

  Patient problems: Burn(s)

  MAUDE report 12522979 ↗
• MalfunctionJun 8, 2018Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE PATIENT'S SKIN WAS REDDENED AFTER A LEVEL 1 SNUGGLE WARM BODY BLANKET (SET AT A TEMPERATURE OF 40 C) WAS USED IN AN OPERATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7584159 ↗
• InjuryApr 27, 2017Device Operates Differently Than Expected; Temperature Problem; Device Operates Differently Than Expected; Temperature Problem

  IT WAS REPORTED THAT THE PATIENT SUSTAINED A SKIN BURN ON THE LOWER LIMBS AFTER A LEVEL 1® SNUGGLE WARM® CONVECTIVE WARMING BLANKET WAS IN USE. THE INITIAL REPORTER NOTED THAT THE DEVICE WAS SET TO WARM TO 44 DEGREES CELSIUS. THE BLANKET WAS IN USE FOR 90 MINUTES DURING A CARDIAC PROCEDURE.

  Patient problems: Burn, Thermal

  MAUDE report 6526701 ↗