FDA Adverse Event
Malfunction
Summary report: N
SILICONE TRACHEOSTOMY TUBE
MDR report key: 178333
·
Received July 22, 1998
Report
- Report Number
- 9611018-1998-00010
- Event Type
- Malfunction
- Date Received
- July 22, 1998
- Report Date
- June 17, 1998
- Manufacturer
- SHERWOOD MEDICAL INDUSTRIES
- Product Code
- BTO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CUSTOMER REPORTS, THE WING OF THE ACTUAL SAMPLE WAS BROKEN. NO PT INJURY IS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SILICONE TRACHEOSTOMY TUBE | TRACHEOSTOMY TUBE | BTO | SHERWOOD MEDICAL INDUSTRIES | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |