N
Patient 1
(B)(4). WE ARE CURRENTLY IN THE PROCESS OF RETRIEVING THE COMPLAINT DEVICE. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF INVESTIGATION.
MAUDE MDR 9736233
- MDR report key
- 9736233
- Report number
- 9611451-2020-00184
- Event key
- 0
- Event type
- 3
- Date received
- 2020-02-20
- 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
- MS. FARANAK GOMAROONI
- Address
- 173 TECHNOLOGY DR., SUITE 100 IRVINE CA 92618 US
- Phone
- 949-949-9494
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | FLEXITRUNK INFANT NASAL TUBING | BZO | FISHER & PAYKEL HEALTHCARE LIMITED | BZO | BC191 | BC191 | 2100801597 | N | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-02-20 | 0 |
Event Narratives#
D
Patient 1
A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE BC191 FLEXITRUNK INFANT NASAL TUBING WAS FOUND TO BE TORN BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.