FDA Adverse Event
Other
Summary report: N
ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM
MDR report key: 952468
·
Received November 20, 2007
Report
- Report Number
- 1725056-2007-00001
- Event Type
- Other
- Date Received
- November 20, 2007
- Date of Event
- October 25, 2007
- Report Date
- November 19, 2007
- Manufacturer
- MEDIVANCE, INC.
- Product Code
- DWJ
- PMA / PMN Number
- K010338
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THE PT ADMITTED TO THE NEURO INTENSIVE CARE UNIT AFTER SUSTAINING A TRAUMATIC BRAIN INJURY. THE PT WAS PLACED ON THE ARCTIC SUN FOR FEVER CONTROL AND ICP MANAGEMENT. NO SKIN ISSUES NOTED DURING OR AT THE CONCLUSION OF THE ARCTIC SUN USE. ON THE FOLLOWING DAY, THE PT WAS NOTED TO HAVE CHANGES IN SKIN COLOR (REDDENED/PURPLE) ON THE RIGHT AND LEFT ABDOMEN AND THE TOP OF THE RIGHT THIGH. A SMALL AREA OF EPIDERMIS ON THE THIGH BLISTERED WHICH IS HEALING WITH CONSERVATIVE TREATMENT. THE TREATMENT EXTENDED THE PT'S HOSPITALIZATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM | TEMPERATURE MANAGEMENT SYSTEM | DWJ | MEDIVANCE, INC. | 20002 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Hospitalization |