FDA Adverse Event
Injury
Summary report: N
HOTDOG PATIENT WARMING BLANKET
MDR report key: 13019759
·
Received December 15, 2021
Report
- Report Number
- MW5106110
- Event Type
- Injury
- Date Received
- December 15, 2021
- Date of Event
- December 1, 2021
- Report Date
- December 14, 2021
- Manufacturer
- AUGUSTINE TEMPERATURE MANAGEMENT, LLC
- Product Code
- DWJ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
IT WAS OBSERVED THAT A REUSABLE PATIENT WARMING BLANKET HAD MULTIPLE AREAS WHERE THE EXTERIOR COVER HAD MELTED. FDA SAFETY REPORT ID #(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1913191 | HOTDOG PATIENT WARMING BLANKET | SYSTEM, THERMAL REGULATING | DWJ | AUGUSTINE TEMPERATURE MANAGEMENT, LLC | B105 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |