MAUDE Adverse Event Report: AUGUSTINE TEMPERATURE MANAGEMENT U101 HOTDOG UNDER BODY WARMING MATTRESS 82 CM (32"); ELECTRIC HEATING PAD

Model Number	U101
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Ischemia (1942); Partial thickness (Second Degree) Burn (2694)
Date of Event	05/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The "pre-existing bruise on the left hip" is a contributing factor to this incident.Bruising indicates vasculature injury, which could more easily lead to secondary injury when combined with prolonged pressure on the hip and warming.
Event or Problem Description
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 assigned by (b)(6) it appears that the incident resulted in blisters that needed medical intervention and prolonged hospitalization.Per augustine investigation: we have been unable to get more specific details about the incident other than the following: the patient was in lateral position undergoing hip surgery and was laying on a "pre-existing bruise on the left hip." the biomedical engineering staff at the hospital performed a full test report on the u101 warming mattress and wc77 controller.They determined that the units are performing within specifications and there is no indication of any malfunction.See section h11 for additional manufacturer narrative.

• Brand Name: U101 HOTDOG UNDER BODY WARMING MATTRESS 82 CM (32")
• Common Device Name: ELECTRIC HEATING PAD
• Manufacturer (Section D): AUGUSTINE TEMPERATURE MANAGEMENT; 15305 minnetonka boulevard; minnetonka MN 55345 1518
• Manufacturer (Section G): AUGUSTINE TEMPERATURE MANAGEMENT; 15305 minnetonka boulevard; minnetonka MN 55345 1518
• Manufacturer Contact: ivona domnisoru ; 15305 minnetonka boulevard; minnetonka, MN 55345-1518 ; 9524653851
• MDR Report Key: 22559900
• Report Number: 3005857264-2025-00008
• Device Sequence Number: 9565350
• Product Code: DWJ
• UDI-Device Identifier: 00855913001510
• UDI-Public: (01)00855913001510(17)260131
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K092807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/21/2025

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 Expiration Date: 01/31/2026
• Device Model Number: U101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown