FDA Adverse Event
Injury
Summary report: N
1282497-2001-00002
MDR report key: 314611
·
Received February 1, 2001
Report
- Report Number
- 1282497-2001-00002
- Event Type
- Injury
- Date Received
- February 1, 2001
- Date of Event
- October 20, 2000
- Report Date
- January 30, 2001
- Manufacturer
- KENDALL CORP
- Product Code
- KNT
- Report Source
- Manufacturer report
Narratives
Description of Event or Problem · 1
THE FOLLOWING WAS REPORTED ON 1/3/2001 BY A MEDWATCH FORM (#1020360), "AT APPROX 1115, THE NURSE INSERTED THE DOBHOFF TUBE WITHOUT RESISTANCE, THE PT WAS CONSCIOUS, NO COUGHING, GAGGING OR SPEECH IMPAIRMENT OCCURRED. AN X-RAY WAS TAKEN TO VERIFY THE PLACEMENT AND THE TUBE HAD PERFORATED THE LUNG." THE CUSTOMER WAS CALLED AND WAS UNABLE TO GIVE ANY FURTHER INFO OF THE INCIDENT OR ABOUT THE PRODUCT CODE, LOT NUMBER OR SAMPLE, OR STATUS ABOUT THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 3792 | KNT | KENDALL CORP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |