FDA Adverse Event
Malfunction
Summary report: N
FLYTE HOOD
MDR report key: 1930484
·
Received November 30, 2010
Report
- Report Number
- 1811755-2010-01841
- Event Type
- Malfunction
- Date Received
- November 30, 2010
- Date of Event
- November 4, 2010
- Report Date
- November 5, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- FXY
- PMA / PMN Number
- K063005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RETURNED TO THE MFR FOR INVESTIGATION. THE INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT LINT WAS COMING OFF THE HOOD DURING A PROCEDURE. THE ACCOUNT WAS CONCERNED THAT SOME OF THE LINT MAY HAVE FALLEN INTO THE SURGICAL SITE. THE SURGICAL SITE WAS IRRIGATED TO REMOVE THE PARTICLES. NO ADD'L TREATMENT WAS GIVEN TO THE PT AS A RESULT OF THIS EVENT. THERE IS NO SIGN OF INFECTION AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLYTE HOOD | SURGICAL APPAREL | FXY | STRYKER INSTRUMENTS KALAMAZOO | 0903070 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |