FDA Adverse Event
Malfunction
Summary report: N
STRYKEFLOW2 WITHOUT TIP (6BX)
MDR report key: 1821721
·
Received August 25, 2010
Report
- Report Number
- 2648666-2010-00366
- Event Type
- Malfunction
- Date Received
- August 25, 2010
- Date of Event
- August 6, 2010
- Report Date
- August 10, 2010
- Manufacturer
- STRYKER ENDOSCOPY PUERTO RICO
- Product Code
- GCX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN THE UNIT WAS OPENED, A HAIR WAS FOUND STUCK ON THE UNIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STRYKEFLOW2 WITHOUT TIP (6BX) | SUCTION/IRRIGATION | GCX | STRYKER ENDOSCOPY PUERTO RICO | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |