FDA Adverse Event
Other
Summary report: N
BAIR HUGGER MODEL 200
MDR report key: 38166
·
Received September 13, 1996
Report
- Report Number
- 2183725-1996-09002
- Event Type
- Other
- Date Received
- September 13, 1996
- Report Date
- September 9, 1996
- Manufacturer
- AUGUSTINE MEDICAL, INC.
- Product Code
- DWJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
BLISTERS WERE NOTICED ON THE PT'S FEET AND ANKLES AFTER REWARMING IN PACU. THE PT WAS WARMED USING CO'S WARMING UNIT AND ANOTHER CO'S BLANKET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BAIR HUGGER MODEL 200 | PATIENT WARMING UNIT | DWJ | AUGUSTINE MEDICAL, INC. | 200 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Other |