FDA Adverse Event
Other
Summary report: N
BAIR HUGGER WARMING SYSTEM
MDR report key: 276621
·
Received May 3, 2000
Report
- Report Number
- 2183725-2000-00002
- Event Type
- Other
- Date Received
- May 3, 2000
- Date of Event
- August 27, 1999
- Report Date
- May 3, 2000
- Manufacturer
- AUGUSTINE MEDICAL INC.
- Product Code
- DWJ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
PT WAS WARMED DURING SURGERY WITH NO BLANKET ATTACHED TO THE WARMING UNIT. PT SUSTAINED SECOND AND THIRD DEGREE BURNS ON THE LOWER EXTREMITIES. BURNS CAUSED BY PRODUCT MISUSE: WARNINGS ARE PROVIDED ON EVERY WARMING UNIT, IN INSTRUCTIONS FOR USE PACKAGED WITH EVERY BLANKET, ON A LABEL ATTACHED TO EVERY BLANKET, IN THE OPERATORS MANUAL AND IN THE SERVICE MANUAL STATING THAT BLANKETS MUST BE USED WITH THE WARMING UNIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BAIR HUGGER WARMING SYSTEM | WARMING UNIT | DWJ | AUGUSTINE MEDICAL INC. | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Other |