FDA Adverse Event
Malfunction
Summary report: N
FLYTE HOOD
MDR report key: 7370201
·
Received March 26, 2018
Report
- Report Number
- 0001811755-2018-00538
- Event Type
- Malfunction
- Date Received
- March 26, 2018
- Date of Event
- March 2, 2018
- Report Date
- May 18, 2018
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- FYA
- PMA / PMN Number
- K060076
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT WHITE DUST PARTICLES CAME OFF OF THE DEVICE DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT WHITE DUST PARTICLES CAME OFF OF THE DEVICE DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 213984 | FLYTE HOOD | GOWN, SURGICAL | FYA | STRYKER INSTRUMENTS-KALAMAZOO | 17082292 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |