FDA Adverse Event
Malfunction
Summary report: N
READY HEAT II (THERMAL BLANKET)
MDR report key: 21459544
·
Received February 25, 2025
Report
- Report Number
- MW5166780
- Event Type
- Malfunction
- Date Received
- February 25, 2025
- Date of Event
- February 17, 2025
- Report Date
- February 20, 2025
- Manufacturer
- TECHTRADE LLC.
- Product Code
- KME
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- RISK MANAGER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
TRANSPORT THERMAL BLANKET READY HEAT II HAS CAUSED REDNESS/BURN TO PATIENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1394074 | READY HEAT II (THERMAL BLANKET) | BEDDING, DISPOSABLE, MEDICAL | KME | TECHTRADE LLC. | 23275M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 MO | Female | Other |