FDA Adverse Event
Malfunction
Summary report: N
VASCUSHUNT
MDR report key: 52540
·
Received November 25, 1996
Report
- Report Number
- 1713910-1996-00031
- Event Type
- Malfunction
- Date Received
- November 25, 1996
- Report Date
- November 25, 1996
- Manufacturer
- RESEARCH MEDICAL INC.
- Product Code
- DQR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DURING THE PRIME PROCEDURE OF A CAROTID SHUNT THE STOPCOCK SEPARATED FROM THE INFLATION LINE. THE PT WAS NOT INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VASCUSHUNT | CAROTID SHUNT | DQR | RESEARCH MEDICAL INC. | NA | 87934 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |