D
Patient 1
THE EVENT IS REPORTED AS: AIR LEAK IN THE CUFF WAS FOUND DURING THE PRE TESTING. XYLOCAINE WAS APPLIED, BUT THE ENDOTRACHEAL TUBE WAS NOT USED ON THE PATIENT.
MAUDE MDR 1765852
- MDR report key
- 1765852
- Report number
- 3003898360-2010-00293
- Event key
- 0
- Event type
- 3
- Date of event
- 2010-05-14
- Date received
- 2010-07-07
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- ANGELA BROWN, MANAGER
- Address
- P.O. BOX 12600 RTP NC 27709 US
- Phone
- 919-919-9194
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SHERIDAN TRACHEAL TUBE, CF, 8.0MM | ENDOTRACHEAL TUBE | TELEFLEX MEDICAL | LNZ | NA | 5-10116 | 01H0900178 | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2010-07-07 | 0 |
Event Narratives#
N
Patient 1
THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.