FDA Adverse Event
Malfunction
Summary report: N
EB CARLENS W/CARINA HOOK
MDR report key: 1935381
·
Received November 16, 2010
Report
- Report Number
- 8040412-2010-00086
- Event Type
- Malfunction
- Date Received
- November 16, 2010
- Report Date
- November 2, 2010
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- CBI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
PRODUCT IS UNAVAILABLE FOR EVALUATION, THEREFORE, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A F/U REPORT WILL BE SENT WHEN INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: THE BALLOON DEFLATED AND INFLATED POORLY DURING INTUBATION. NO INJURIES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EB CARLENS W/CARINA HOOK | ENDOBRONCHIAL TUBE | CBI | TELEFLEX MEDICAL | NA | 09JE41 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |