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	Skin Tears (2516); Partial thickness (Second Degree) Burn (2694); Skin Maceration (4841)
Date of Event	02/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Liposuction was performed on the sacrum and lower back (with tumescence) during the initial 48 minutes of the procedure.That area was then in contact with the warming mattress for nearly 5 hours.Proper use training is to "avoid heating the vasoconstricted/de-vascularized skin by moving the warming pad so that it is only contacting adequately perfused skin." in the ifu p/n 2064, we warn that "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." proper mattress placement for beach chair position is outlined in m131 and included in training materials.
Event or Problem Description
As described by the reporter that notified the manufacturer: adult patient underwent a long cosmetic surgery procedure "liposuction (prone) - 48 mins, liposuction (supine) - 107 mins, breast reduction (supine) - 202 mins, abdominoplasty (supine/beach chair) - 139 mins; no skin injury noted after liposuction was completed in the prone positioning.Skin injury noted in pacu by [nurse], contacted md about skin occurrence.Skin injury was not noted by or staff during surgery, after drapes removed or during transfer to stretcher bed." the injury was described as "left medial buttock - skin injury" and "right medial buttock - small skin injury." the injury was between 1-10 sq inches (in total) and described as 2nd degree.It was linear in shape and crossed intergluteal cleft.The patient was treated post op with carboxyl gel , alastin nectar, medical grade honey and was also prescribed hyperbaric treatment.Per investigation, the root cause was determined to be a combination of a few factors 1.The repeated movement/repositioning throughout the procedure, particularly from supine to beach chair, likely caused some skin sheer on the buttocks as the body shifted and moved.2.Maceration and/or irritation of the skin from pooling fluids in beach chair position could have contributed to the injury.The reporter mentioned three different fluids that could have pooled in that area (tumescent fluid, drainage from prone liposuction ports, and ns with diluted betadine wash).3.Warming may have been an additional contributing factor even though the mattress was warming within specifications.It is also possible that there was some folding or rucking that could occur with the warming mattress when the table was bent into beach chair position rather than being set-up specifically for beach chair position at the start.The warming mattress was returned to for evaluation and passed all safety and functional tests.It did not malfunction and was performing per specification.See section h11 for additional manufacturer narrative.

• 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: 24944666
• Report Number: 3005857264-2026-00003
• Device Sequence Number: 17462334
• Product Code: DWJ
• UDI-Device Identifier: 00855913001527
• UDI-Public: (01)00855913001527(17)261231
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/21/2026

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: 04/03/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2024
• 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: 54 YR
• Patient Sex: Female
• Patient Weight: 61 KG