FDA Adverse Event
Malfunction
Summary report: N
MALLINCKRODT
MDR report key: 4212215
·
Received March 19, 2014
Report
- Report Number
- 2936999-2014-00256
- Event Type
- Malfunction
- Date Received
- March 19, 2014
- Date of Event
- February 14, 2014
- Report Date
- October 30, 2014
- Manufacturer
- COVIDIEN
- Product Code
- BTS
- PMA / PMN Number
- K771219
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- N
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 165346 | MALLINCKRODT | ENDOBRONCHIAL TUBE LEFT/RIGHT | BTS | COVIDIEN | 201311069X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |