FDA Adverse Event
Malfunction
Summary report: N
MICROVASIVE
MDR report key: 34520
·
Received July 2, 1996
Report
- Report Number
- 34520
- Event Type
- Malfunction
- Date Received
- July 2, 1996
- Date of Event
- June 25, 1996
- Report Date
- June 27, 1996
- Manufacturer
- MICROVASIVE BOSTON SCIENTIFIC CORP.
- Product Code
- FFK
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CT, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
BASKET RETRIEVAL DEVICE DID NOT GO UP THE SECOND TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICROVASIVE | STONE RETRIEVAL BASKET | FFK | MICROVASIVE BOSTON SCIENTIFIC CORP. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR |