MAUDE Adverse Event Report: Nuance Medical, LLC McKesson; Portable Cryotherapy Treatment Kit

Model Number	73
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction

• Brand Name: McKesson
• Common Device Name: Portable Cryotherapy Treatment Kit
• Manufacturer (Section D): Nuance Medical, LLC; 5931 sea lion place; unit 113; carlsbad CA 92010
• Manufacturer Contact: alan dye ; 5931 sea lion place; suite 113; carlsbad, CA 92010 ; +1(760)585-7741
• MDR Report Key: 50670655
• Report Number: 3010543854-2026-08261
• Device Sequence Number: 10158709
• Product Code: GEH
• UDI-Device Identifier: 20612479193950
• UDI-Public: 20612479193950
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K130995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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
• Device Model Number: 73
• Device Catalogue Number: 9000-024
• Device Lot Number: N2612702
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/08/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown