FDA Adverse Event
Malfunction
Summary report: N
STRYKEFLOW DISPOSABLE SUCTION/IRRIGATOR WITH DISPOSABLE TIP
MDR report key: 16635061
·
Received March 29, 2023
Report
- Report Number
- 16635061
- Event Type
- Malfunction
- Date Received
- March 29, 2023
- Date of Event
- March 9, 2023
- Report Date
- March 17, 2023
- Manufacturer
- STRYKER CORPORATION
- Product Code
- QOJ
- UDI-DI
- 07613327061369
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- TN
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
DISCOLORED FLUID LEAKING FROM THE BATTERY ONTO THE FLOOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 910072 | STRYKEFLOW DISPOSABLE SUCTION/IRRIGATOR WITH DISPOSABLE TIP | APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED | QOJ | STRYKER CORPORATION | 0250070520 | 22343FG2 | 07613327061369 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25915 DA | Male |