FDA Adverse Event
Other
Summary report: N
10FR X 55" ENTRIFLEX W/STYLET
MDR report key: 3779508
·
Received April 23, 2014
Report
- Report Number
- 9612030-2014-00024
- Event Type
- Other
- Date Received
- April 23, 2014
- Report Date
- April 11, 2014
- Manufacturer
- COVIDIEN
- Product Code
- FPD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(4) 2014 THAT A PT HAD AN ADVERSE EVENT WHILE THE FEEDING TUBE WAS IN PLACE. THE CUSTOMER STATES THAT A (B)(6) MALE PT WAS HOSPITALIZED IN THE ICU ON (B)(6) 2013 WHERE HE REMAINED FOR 2 WEEKS AND RECEIVED INTRAVENOUS ANTIBIOTIC TREATMENT. ACCORDING TO THE PEG/J PROCEDURE, THE NASO-INTESTINAL TUBE WAS PLACED ENDOSCOPICALLY. THE SYMPTOMS ANOREXIA AND FEVER PRESENTED ON THE SAME DAY ((B)(6) 2013) AS THE ASPIRATION PNEUMONIA WAS DIAGNOSED. IN (B)(6) 2013 THE PT DIED, CAUSE OF DEATH WAS REPORTED AS ASPIRATION PNEUMONIA. THE TREATING NEUROLOGIST CLARIFIED THAT THE ASPIRATION PNEUMONIA IS NOT RELATED TO DUODOPA OR THE NJ TUBING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 245859 | 10FR X 55" ENTRIFLEX W/STYLET | FEEDING TUBE | FPD | COVIDIEN | 8884721055 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Other |