FDA Adverse Event
Malfunction
Summary report: N
STND TRACH CARE TRAY W/PROXDE
MDR report key: 819233
·
Received February 8, 2007
Report
- Report Number
- 9612030-2007-00009
- Event Type
- Malfunction
- Date Received
- February 8, 2007
- Report Date
- January 25, 2007
- Manufacturer
- TYCO HEALTHCARE/KENDALL
- Product Code
- LRQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
PER THE CUSTOMER, A SAMPLE WILL NOT BE RETURNED FOR INVESTIGATION. AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO MFR THAT A CUSTOMER HAD A PROBLEM WITH A TRACH BRUSH. THE CUSTOMER STATED, THAT A PATIENT HAD A TRACH BRUSH BREAK AND FALL DOWN HIS TRACH. HE WAS ABLE TO RETRIEVE IT AND NO MEDICAL ATTENTION WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STND TRACH CARE TRAY W/PROXDE | TRACH BRUSH | LRQ | TYCO HEALTHCARE/KENDALL | 47885 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |