MAUDE Adverse Event Report: HYPOTHERMIA DEVICES INC. KELVI; ANKLE PRO SMART WRAP

Model Number	ASM-0109
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Blister (4537)
Date of Event	11/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Athlete developed a blister approximately one inch in diameter on the lateral part of the right ankle while using a contrast protocol.The blister healed fully and the patient required no outside medical intervention.

• Brand Name: KELVI
• Common Device Name: ANKLE PRO SMART WRAP
• Manufacturer (Section D): HYPOTHERMIA DEVICES INC.; 413 n.oak street; inglewood CA 90302
• Manufacturer (Section G): HYPOTHERMIA DEVICES INC DBA KELVI; 413 n. oak street; inglewood CA 90302
• Manufacturer Contact: patrick riley ; 413 n. oak street; inglewood, CA 90302 ; 6197565749
• MDR Report Key: 15919839
• Report Number: 3015252349-2022-00001
• Device Sequence Number: 4508398
• Product Code: ILO
• UDI-Device Identifier: 00850001185059
• UDI-Public: 00850001185059
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 12/05/2022

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: ASM-0109
• Device Catalogue Number: KELVI20004
• Device Lot Number: 2038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2020
• 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: PRO CONSOLE, ASM-0029; UMBILICAL, ASM-0100
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male