D
Patient 1
PATIENT WAS BEING INTUBATED WITH TAPERGARD SUBGLOTTIC ENDOTRACHEAL TUBES. CUFF DID NOT HOLD AIR, SO PATIENT NEEDED TO BE REINTUBATED. UNCLEAR IF THIS IS AN EQUIPMENT FAILURE OR ANATOMY ISSUE.
MAUDE MDR 9840704
- MDR report key
- 9840704
- Report number
- 9840704
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-02-28
- Date received
- 2020-03-17
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 500
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- U
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SHILEY | TUBE, TRACHEAL (W/WO CONNECTOR) | COVIDIEN LLC | BTR | 19A0830JZX/19J1007JZX | * | * |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-17 | 0 |