FDA Adverse Event
Malfunction
Summary report: N
RAPIDO ADVANCE INNER GUIDING CATHETER 50 COMPACT
MDR report key: 1043301
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-33353
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- February 11, 2008
- Report Date
- February 11, 2008
- Manufacturer
- EXTERNAL MANUFACTURER
- Product Code
- LWS
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RAPIDO ADVANCE INNER GUIDING CATHETER 50 COMPACT | * | LWS | EXTERNAL MANUFACTURER | 7720 | 6083151 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | THE DEVICE 7720 WAS USED DURING THE EVENT.| THE DEVICE 6720 608315 WAS USED DURING THE EVENT. |