MAUDE Adverse Event Report: MMJ SA DE CV (USD) WARMTOUCH; SYSTEM, THERMAL REGULATING

Model Number	5016000
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	12/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient using a thermal blanket on the upper limbs, in conjunction with the warmtouch heating equipment, suffered a thermal burn on the right arm.The surrounding area turned red, and there were two spots, as if the patient's skin was loose.A scalpel was used, and the area was cleaned with alcoholic chlorhexidine.A consultation with a plastic surgeon diagnosed the injury as a thermal burn.The hospitalization was extended due to this event.
Additional Manufacturer Narrative
D10 concomitant product: 5030870, wt caredrape upper (lot# unknown).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: WARMTOUCH
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• Manufacturer (Section G): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21167284
• Report Number: 2936999-2025-00019
• Device Sequence Number: 14536923
• Product Code: DWJ
• UDI-Device Identifier: 10884521141100
• UDI-Public: 10884521141100
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K123083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/16/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5016000
• Device Catalogue Number: 5016000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 01/16/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE NOTES ON H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown