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

Model Number ASM-0109

Device Problem Excessive Heating (4030)

Patient Problem Blister (4537)

Event Date 11/15/2021

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 304866682
• Report Number: 3015252349-2022-00001
• Device Sequence Number: 1
• Product Code: ILO
• UDI-Device Identifier: 00850001185059
• UDI-Public: 00850001185059
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2020
• 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: PRO CONSOLE, ASM-0029; UMBILICAL, ASM-0100
• Patient Outcome(s): Other
• Patient Sex: Male