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	05/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although the reporter describes this as a thermal burn, atm suspects it is a skin reaction related to chemicals due to the location of the redness and the pattern of the redness.Also, product misuse was a contributing factor to the reported patient injury.The product was used in violation of the precaution "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".Warmth could have contributed to the injury.
Event or Problem Description
As described by the reporter that notified augustine temperature management's distributor in australia: "hip replacement surgery - time: 1.5-2 hours.Patient was not noticed to have the burn as they had spinal and ga onboard- recovery staff discovered the burn on handover of the patient." the injury is described as: "2nd degree burn to the left hip and abdominal area with a size of 1sq in to 10 sq inches.".The reporter sent images and mentioned: "patient required additional care needs- stay in icu, review from burns unit and general surgeon." no additional details on the follow-up care were provided.According to the reporter, the injury "did not result in permanent impairment of a body function or permanent damage to a body structure." per augustine's investigation: the underbody mattress u102 s# (b)(6) was tested according to company procedures and was found to perform per specification and passed all safety and functional tests.Visual inspection shows the mattress with a lot of folds and wrinkles but is otherwise free of any damages or abnormalities; this did not adversely affect the performance of the device.Per the images sent, the areas on the patient that show signs of redness and blisters are mainly in the skin crease areas near the abdomen and the creases near the hip flexor.These areas were not touched by atm's warming mattress or any warming device.The mattress overlay was confirmed to be flat on the operating table and not folded up against the patient; a bolster was used at the iliac crest and another bolster was used at the back of the patient plus they used an upper arm support.Although the reporter describes this as a thermal burn, atm suspects it is an adverse skin reaction related to chemicals due to the location of the redness and the streaking pattern of the redness and blistering.In our ifu 2064 in precautions we advise "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".Heat could have contributed to the adverse reaction.The customer asked in the incident report form, "does it have the ability to warm a liquid to a degree that could sustain burns?" the answer is 'no.' the mattress warms to a max heat setting of 40c.That is not warm enough to cause thermal injury on perfused tissue.As long as there was sufficient blood flow to the warmed tissue, the only explanation for the injury is an adverse reaction to pooling chemicals.It also corresponds with the pattern and location of the injury shown in the pictures.Atm has decided to file this emdr, since no additional details/ or clarification was obtained in regard to the medical intervention required by this customer.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 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: 21223255
• Report Number: 3005857264-2025-00006
• Device Sequence Number: 8603604
• Product Code: DWJ
• UDI-Device Identifier: 00855913001527
• UDI-Public: (01)00855913001527(17)251130
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/23/2025

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: 11/30/2025
• Device Model Number: U102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2023
• 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; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 113 KG