FDA Adverse Event
Malfunction
Summary report: N
HOTDOG PATIENT WARMING
MDR report key: 15438397
·
Received September 15, 2022
Report
- Report Number
- MW5112088
- Event Type
- Malfunction
- Date Received
- September 15, 2022
- Date of Event
- August 22, 2022
- Report Date
- September 14, 2022
- Manufacturer
- AUGUSTINE TEMPERATURE MANAGEMENT, LLC
- Product Code
- DWJ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MI, US
- Reporter Occupation
- 501
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
HOTDOG AIR-FREE CONDUCTIVE PT WARMING BLANKET MELTED WHILE IN USE DURING A SURGICAL PROCEDURE. NO HARM TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2356219 | HOTDOG PATIENT WARMING | SYSTEM, THERMAL REGULATING | DWJ | AUGUSTINE TEMPERATURE MANAGEMENT, LLC | B105 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |