FDA Adverse Event
Injury
Summary report: N
ESOPHAGEAL TEMPERATURE PROBE
MDR report key: 19510879
·
Received June 10, 2024
Report
- Report Number
- MW5156098
- Event Type
- Injury
- Date Received
- June 10, 2024
- Date of Event
- May 22, 2024
- Report Date
- June 6, 2024
- Manufacturer
- CIRCA SCIENTIFIC, INC.
- Product Code
- FLL
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TN, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PROBE INSERTED INTO THE ESOPHAGUS BUT WOULD NOT READ OR REPOSITION. NEW PROBE OBTAINED, INSERTED, AND WORKED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 189518 | ESOPHAGEAL TEMPERATURE PROBE | THERMOMETER, ELECTRONIC, CLINICAL | FLL | CIRCA SCIENTIFIC, INC. | CS-21EP | 004677 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Male | Required Intervention |