MAUDE Adverse Event Report: NUANCE MEDICAL, LLC MCKESSON; REUSEABLE CRYOTHERAPY TREATMENT KIT

Model Number	33
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Plantar wart removal.Customer said the insert stated to hold it on the place of application for 20 secs.They believe this is too long.Patient suffered burn like injury to toe.Medical treatment was necessary.
Additional Manufacturer Narrative
Multiple attempts were made to gain additional information.We examined the returned product and found it to be intact, with no visible damage or punctures, and that the cap was secure.The canister was test-sprayed 5 times and dispensed properly.Design master record 2158 was reviewed and there was no nonconformity during the production and product inspection.Root cause could not be determined.Returned products were inspected and there is no performance issue.The can is in good condition and spraying as intended.

• Brand Name: MCKESSON
• Common Device Name: REUSEABLE CRYOTHERAPY TREATMENT KIT
• Manufacturer (Section D): NUANCE MEDICAL, LLC; 5391 sea lion place; suite 113; carlsbad CA 92010
• Manufacturer (Section G): NUANCE MEDICAL, LLC; 5391 sea lion place; suite 113; carlsbad CA 92010
• Manufacturer Contact: alan dye ; 5391 sea lion place; suite 113; carlsbad, CA 92010 ; 7605857741
• MDR Report Key: 24424080
• Report Number: 3010543854-2026-02232
• Device Sequence Number: 20346694
• Product Code: GEH
• UDI-Device Identifier: 20612479193974
• UDI-Public: 20612479193974
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/14/2026

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 Model Number: 33
• Device Lot Number: N250221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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