FDA Adverse Event
Injury
Summary report: N
LASER-STAR CATHETER
MDR report key: 256180
·
Received December 17, 1999
Report
- Report Number
- 2020638-1999-00030
- Event Type
- Injury
- Date Received
- December 17, 1999
- Date of Event
- November 18, 1999
- Report Date
- November 19, 1999
- Manufacturer
- CORDIS WEBSTER, INC.
- Product Code
- GEX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
FOLLOWING THE "DMR" PROCEDURE, PT DEVELOPED A PERICARIDAL EFFUSION AND WAS TRANSFERRED TO THE CORONARY CARE UNIT FOR OBSERVATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LASER-STAR CATHETER | THERAPEUTIC CATHETER | GEX | CORDIS WEBSTER, INC. | D-1209-11-SI | 9080893 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Life Threatening | NO INFO AT THIS TIME. |