FDA Adverse Event
Other
Summary report: N
BAIR HUGGER WARMING SYSTEM
MDR report key: 278391
·
Received May 18, 2000
Report
- Report Number
- 2183725-2000-00003
- Event Type
- Other
- Date Received
- May 18, 2000
- Date of Event
- April 28, 2000
- Report Date
- May 18, 2000
- Manufacturer
- AUGUSTINE MEDICAL INC.
- Product Code
- DWJ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PT WAS WARMED DURING SURGERY AND SUSTAINED SECOND AND THIRD DEGREE BURNS ON THE FEET. PT HAD POOR VASCULAR PERFUSION PRIOR TO ABDOMINAL AORTIC ANEURYSM SURGERY AND WAS CROSSCLAMPED. INSTRUCTIONS SPECIFICALLY WARN AGAINST WARMING UNDER THESE PT AND SURGICAL CONDITIONS.
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 | UNKNOWN | Other |