MAUDE Adverse Event Report: C2DX INC. T PUMP; Pack, hot or cold, water circulating

Catalog Number	8002062026
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	01/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was reported to have a severe allergic reaction.
Additional Manufacturer Narrative
Pad used with t pump is non-latex.See attached letter.

• Brand Name: T PUMP
• Common Device Name: Pack, hot or cold, water circulating
• Manufacturer (Section D): C2DX INC.; 555 e eliza st suite a; schoolcraft MI 49087
• MDR Report Key: 24184079
• Report Number: 3015489752-2026-00001
• Device Sequence Number: 15947496
• Product Code: ILO
• UDI-Device Identifier: 10850007350083
• UDI-Public: 10850007350083
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K073675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/26/2026

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 Catalogue Number: 8002062026
• 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: 01/16/2026
• Initial Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (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 Sex: Unknown