FDA Adverse Event
Malfunction
Summary report: N
HYPOTHERMIA DEVICES INC. (DBA KELVI)
MDR report key: 17240504
·
Received June 30, 2023
Report
- Report Number
- 3015252349-2023-00001
- Event Type
- Malfunction
- Date Received
- June 30, 2023
- Date of Event
- May 5, 2023
- Report Date
- June 29, 2023
- Manufacturer
- HYPOTHERMIA DEVICES INC
- Product Code
- ILO
- UDI-DI
- 00850001185042
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1328684 | HYPOTHERMIA DEVICES INC. (DBA KELVI) | KNEE WRAP | ILO | HYPOTHERMIA DEVICES INC | ASM-0111 | 2113 | 00850001185042 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Other | ASM-0111, KNEE WRAP| ASM-0300, PRO-E CONSOLE |