MAUDE Adverse Event Report: Covidien llc WarmTouch; SYSTEM, THERMAL REGULATING

Model Number	5016000
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction

• Brand Name: WarmTouch
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): Covidien llc; 6135 gunbarrel ave; boulder,co
• Manufacturer (Section G): Covidien llc; 6135 gunbarrel ave; boulder,co
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112--439 ; +1(800)646-4633
• MDR Report Key: 50954957
• Report Number: 2936999-2026-00413
• Device Sequence Number: 9623876
• Product Code: DWJ
• UDI-Device Identifier: 10884521141100
• UDI-Public: (01)10884521141100(11)160614
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K123083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 06/14/2016
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown