Hot Dog Underbody Warming Mattress, 82 cm (32in) U101Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00855913001510), received between Jul 21, 2025 and Jul 21, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2025Use of Device Problem; Use of Device Problem

  WE LEARNED ABOUT A POTENTIAL ADVERSE EVENT OCCURRING AT HOSPITAL (B)(6) ON (B)(6) 2025, DURING A CALL FROM A BIOMED ASKING ABOUT PRODUCT TESTING INSTRUCTIONS. WE WERE NOT GIVEN ANY DETAILS ABOUT THE PATIENT, INJURY, PROCEDURE, NOR ANY OTHER DETAILS, ONLY (B)(6) TEMPERATURE MANAGEMENT DEVICE P/N AND SERIAL #. DESPITE MULTIPLE ATTEMPTS TO GET ADDITIONAL INFORMATION, WE DID NOT GET ANY DETAILS ABOUT THE INCIDENT, UNTIL (B)(6). ON 07-14-2025 , (B)(6) MEDICAL DEVICES SENTINEL NETWORK HEALTH (B)(6) NOTIFIED AUGUSTINE) TEMPERATURE MANAGEMENT ABOUT AN INCIDENT THAT OCCURED AT (B)(6). IN THE REPORT, AS DETAILED BY THE REPORTER (TRANSLATED FROM FRENCH): "THE PATIENT WAS NOTED TO HAVE A PRE-EXISTING BRUISE ON THE LEFT HIP. THIS AREA WAS IN PROLONGED CONTACT WITH THE INTRAOPERATIVE WARMING DEVICE DURING SURGERY ON THE RIGHT HIP. A V.A.C. (VACUUM ASSISTED CLOSURE) DRESSING WAS APPLIED AND HOSPITALIZATION WAS CARRIED OUT IN THE ORTHOPEDIC SURGERY UNIT." WE CONSIDER (B)(6) THE DATE WHEN WE BECAME AWARE, AS UP UNTIL THAT DATE, WE DID NOT HAVE ANY DETAILS ABOUT THE PATIENT, INJURY, HOSPITALIZATION, ETC., THUS AN ASSESSMENT ABOUT REPORTABILITY COULD NOT BE MADE UP UNTIL THAT POINT. BY THE CODES ASSI

  Patient problems: Ischemia; Partial thickness (Second Degree) Burn

  MAUDE report 22559900 ↗