FDA Adverse Event
Other
Summary report: N
DISPOSABLE CYTOLOGY BRUSH
MDR report key: 1085175
·
Received July 30, 2008
Report
- Report Number
- 9710641-2008-00108
- Event Type
- Other
- Date Received
- July 30, 2008
- Date of Event
- January 1, 2008
- Report Date
- July 29, 2008
- Manufacturer
- CONMED CORP.
- Product Code
- FDX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVAL. WE HAVE MADE SEVERAL ATTEMPTS TO GAIN FURTHER ADD'L INFO THAT WENT UNANSWERED. WE WERE RECENTLY INFORMED THAT THE INDIVIDUAL THAT WOULD BE ABLE TO PROVIDE US WITH FURTHER INFO HAS BEEN ON VACATION AND WILL SOON PROVIDING ANSWERS TO OUR QUESTIONS. ONCE THE LOCATION OF THE DEVICE IS DETERMINED, WE WILL ARRANGE FOR SHIPMENT BACK TO CONMED FOR FORMAL EVAL OF DEVICE. I WILL FILE A SUPPLEMENTAL REPORT ONCE THE DEVICE IS REC'D AND EVALUATED.
Description of Event or Problem · 1
IT WAS REPORTED THAT "AT THE PRESSING JOINING POINT THE WIRE WITH THE BRUSH SLIPPED OUT AND STAYED IN THE PT. THEY COULD TAKE AWAY THAT PART ONLY AFTER A ONE HR OPERATION."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DISPOSABLE CYTOLOGY BRUSH | BRUSH | FDX | CONMED CORP. | NA | 0801301 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |