N
Patient 1
FOREIGN REPORT SOURCE: (B)(6).
MAUDE MDR 9833561
- MDR report key
- 9833561
- Report number
- 3012307300-2020-02018
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-02-14
- Date received
- 2020-03-16
- 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
- DAVE HALVERSON
- Address
- 6000 NATHAN LANE NORTH MINNEAPOLIS, MN US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PORTEX UNIPERC INNER CANNULAE | TUBE, TRACHEOSTOMY (W/WO CONNECTOR) PRODUCT CODE: BTO | SMITHS MEDICAL ASD, INC. | BTO | 100/899/070CZ | 100/899/070CZ | 3827426 | N | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-16 | 0 |
Event Narratives#
D
Patient 1
INFORMATION WAS RECEIVED THAT THE BLUE LOCKSYSTEM ON A SMITHS MEDICAL REGARDING A PORTEX UNIPERC INNER CANNULA DID NOT WORK. NO ADVERSE PATIENT EFFECTS WERE REPORTED.