MAUDE Adverse Event Report: AUGUSTINE TEMPERATURE MANAGEMENT U102 HOTDOG UNDER BODY WARMING MATTRESS 127 CM ( 50"); ELECTRIC HEATING PAD

Model Number	U102
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Caustic/Chemical Burns (2549); Partial thickness (Second Degree) Burn (2694)
Date of Event	12/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As described by the reporter that notified the manufacturer: "clavicle fracture surgery with plate fixation, performed in the beach-chair position.The patient initially complained of pain in the buttock.There were no problems during the surgery, but at the end of the procedure the patient was visibly and profusely sweating.A burn was observed on the buttock, in the intergluteal cleft and adjacent to the anus." the injury was reported to be "second-degree burn on the buttock, in the area between the buttocks and adjacent to the anus.Medical treatment and protocol for second-degree burns were initiated." specific details about said treatment were not provided.According to the reporter, the injury did not result in permanent impairment of a body function or permanent damage to a body structure, nor did it necessitate medical or surgical intervention to preclude such.Per augustine's investigation: the warming mattress was returned for evaluation and passed all safety and functional tests.It did not malfunction and was performing per specification.As long as the products were used in accordance with the ifu, a thermal injury is not possible.The patient underwent clavicle fracture surgery with plate fixation that was performed in the beach-chair position, with the hotdog u102 mattress overlay below the patient from the legs to the lower back.The initial verbal communication indicated that a thin barrier was not used between the patient and the mattress.A thin barrier is required per the ifu to avoid direct skin contact between the patient and any residual cleaning chemicals.There were no problems observed or reported during the surgery.Following surgery, the patient initially complained of pain in the buttocks.It is unknown if there was a preexisting issue with the patient in this area.An injury to the epidermis was observed on the buttocks, in the intergluteal cleft, and adjacent to the anus.The location of the injury points to two primary causes: 1) beach chair position with a slight lateral lean put high pressure on the right gluteus maximus, which experienced the largest red area.2) pooling liquids or residual cleaning fluids most likely caused a chemical burn because some areas of the injury were simply not in direct contact with the heated surface of the mattress.Atm warns in ifu p/n 2064: "the risk of skin irritation caused by pooling of surgical prep solutions under the patient may increase with warming; ensure that surgical prep solution instructions for use are followed." warming may have been a contributing factor to the adverse skin reaction but could not be the primary root cause based on the investigation.The location of the injury points away from a thermal burn.We believe the root cause was patient skin contact with residual cleaning chemicals and fluids that pooled on the mattress.Harsh disinfectants will cause chemical burns and skin reactions upon prolonged contact.These injuries will occur with and without additional heat applied to the skin (in the case of active warming).The 5 items from the rma (a controller, p/n wc77 s# (b)(6), a mattress, p/n u102 s# (b)(6), and 3 cables, a101 lot # 2404, a412-in lot # n60023 and an a112 lot # 2428) were investigated in-house and were found to function per specification.Atm is filing this emdr because this is considered a serious injury per d1041- vigilance and mdr procedure, rev r.See section h11 for additional manufacturer narrative.
Additional Manufacturer Narrative
The reporter described the injury as a "burn." augustine temperature management concludes it is most likely a chemical burn caused by prolonged skin exposure to residual cleaning chemicals and pooled fluids, combined with heat from warming and occlusion from excessive pressure.

• Brand Name: U102 HOTDOG UNDER BODY WARMING MATTRESS 127 CM ( 50")
• Common Device Name: ELECTRIC HEATING PAD
• Manufacturer (Section D): AUGUSTINE TEMPERATURE MANAGEMENT; 15305 minnetonka boulevard; minnetonka MN 55345
• Manufacturer (Section G): AUGUSTINE TEMPERATURE MANAGEMENT; 15305 minnetonka boulevard; minnetonka MN 55345
• Manufacturer Contact: ivona domnisoru ; 15305 minnetonka boulevard; minnetonka, MN 55345 ; 9524653511
• MDR Report Key: 24024130
• Report Number: 3005857264-2026-00001
• Device Sequence Number: 13400540
• Product Code: DWJ
• UDI-Device Identifier: 00855913001527
• UDI-Public: (01)00855913001527(17)271130
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/09/2026

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: U102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 45 YR
• Patient Sex: Male
• Patient Weight: 84 KG