FDA Adverse Event
Malfunction
Summary report: N
STRKEFLOW2 WITHOUT TIP (6BX)
MDR report key: 1963497
·
Received January 11, 2011
Report
- Report Number
- 2648666-2011-00010
- Event Type
- Malfunction
- Date Received
- January 11, 2011
- Date of Event
- December 30, 2010
- Report Date
- December 30, 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 THERE WAS HAIR INSIDE THE PACKAGING OF THE UNIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STRKEFLOW2 WITHOUT TIP (6BX) | SUCTION/IRRIGATION | GCX | STRYKER ENDOSCOPY PUERTO RICO | 10334FG2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |