FDA Adverse Event
Injury
Summary report: N
4 FR S/L GROSHONG NXT CLEARVUE
MDR report key: 1050293
·
Received May 22, 2008
Report
- Report Number
- 3006260740-2008-00001
- Event Type
- Injury
- Date Received
- May 22, 2008
- Date of Event
- April 30, 2008
- Report Date
- April 30, 2008
- Manufacturer
- C. R. BARD INC. (BASD)
- Product Code
- LJS
- PMA / PMN Number
- K034020
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MFR AT THIS TIME FOR EVAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LINE WAS REMOVED DUE TO REDNESS, SWELLING AND INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4 FR S/L GROSHONG NXT CLEARVUE | LJS | C. R. BARD INC. (BASD) | RERG0265 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |