MAUDE Adverse Event Report: HYPOTHERMIA DEVICES INC HYPOTHERMIA DEVICES INC. (DBA KELVI); KNEE WRAP

Model Number	ASM-0111
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Blister (4537)
Date of Event	05/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
An athlete was using a knee wrap on their thigh and initiated a contrast treatment with a temperature setting of 102 degrees fahrenheit.During the treatment the athlete complained of the wrap being too hot so the athletic trainer removed the wrap and inspected the area.The athlete"s thigh developed a small blister, no medical treatment was necessary due to the minor injury.A representative notified kelvi of the issue and returned the device to the manufacturing site.

• Brand Name: HYPOTHERMIA DEVICES INC. (DBA KELVI)
• Common Device Name: KNEE WRAP
• Manufacturer (Section D): HYPOTHERMIA DEVICES INC; 413 north oak street; inglewood CA 90302
• Manufacturer (Section G): HYPOTHERMIA DEVICES INC.; 413 north oak street; inglewood CA 90302
• Manufacturer Contact: patrick riley ; 413 north oak street; inglewood, CA 90302
• MDR Report Key: 17240504
• Report Number: 3015252349-2023-00001
• Device Sequence Number: 6708262
• Product Code: ILO
• UDI-Device Identifier: 00850001185042
• UDI-Public: 0100850001185042
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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: Repair,Replace
• Type of Report: Initial
• Report Date (Section B): 06/29/2023

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: ASM-0111
• Device Catalogue Number: KLV20003
• Device Lot Number: 2113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2021
• 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: ASM-0111, KNEE WRAP; ASM-0300, PRO-E CONSOLE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male