FDA Adverse Event
Injury
Summary report: N
ESOPHAGEAL TEMPERATURE PROBE 9 FR 400 SERIES
MDR report key: 3101333
·
Received May 3, 2013
Report
- Report Number
- MW5030081
- Event Type
- Injury
- Date Received
- May 3, 2013
- Date of Event
- May 2, 2013
- Report Date
- May 3, 2013
- Manufacturer
- GE HEALTH CARE
- Product Code
- FLL
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MO, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
INTRA-OPERATIVELY GENERAL PURPOSE TEMP PROBE GAVE INACCURATE READINGS. VARIED BY 5 DEGREES/OPERATING ROOM TEAM. DAVINCI HYSTERECTOMY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 195482 | ESOPHAGEAL TEMPERATURE PROBE 9 FR 400 SERIES | GENERAL PURPOSE TEMP PROBE | FLL | GE HEALTH CARE | 400 SERIES | 30885671 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Required Intervention |