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

Model Number ASM-0111

Device Problem Excessive Heating (4030)

Patient Problem Blister (4537)

Event Date 05/05/2023

Event Type  malfunction  

Event 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)
• Type of Device: 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
• MDR Text Key: 318220863
• Report Number: 3015252349-2023-00001
• Device Sequence Number: 1
• Product Code: ILO
• UDI-Device Identifier: 00850001185042
• UDI-Public: 0100850001185042
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ASM-0111, KNEE WRAP; ASM-0300, PRO-E CONSOLE
• Patient Outcome(s): Other
• Patient Sex: Male