FDA Adverse Event
Other
Summary report: N
BIVONA CUSTOMIZED FLEXTEND TRACHEOSTOMY TUBE
MDR report key: 274408
·
Received April 18, 2000
Report
- Report Number
- 1824231-2000-00001
- Event Type
- Other
- Date Received
- April 18, 2000
- Report Date
- April 17, 2000
- Manufacturer
- BIVONA MEDICAL TECHNOLOGIES
- Product Code
- BTO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT VENTILATED ONLY ON RIGHT SIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIVONA CUSTOMIZED FLEXTEND TRACHEOSTOMY TUBE | TRACHEOSTOMY TUBE, CUFFED | BTO | BIVONA MEDICAL TECHNOLOGIES | COOASFT674.0103 | CL17591 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Hospitalization| R |