N
Patient 1
(B)(4).
MAUDE MDR 8864289
- MDR report key
- 8864289
- Report number
- 3003898360-2019-00951
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-07-09
- Date received
- 2019-08-06
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- KATHARINE TARPLEY
- Address
- 3015 CARRINGTON MILL BLVD MORRISVILLE NC 27560 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 | HUDSON ET TUBE, SHER-I-BRONCH, LS, 37 FR | TUBE, TRACHEAL/BRONCHIAL, DIFF | TELEFLEX MEDICAL | CBI | 5-16037 | 73K1600450 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-08-06 | 0 |
Event Narratives#
D
Patient 1
THE CUSTOMER REPORTED "CONNECTOR SWIVEL WASN'T FIXATED". ATTEMPTS MADE TO OBTAIN INFORMATION ON PATIENT CONDITION. NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.