FDA Adverse Event
Injury
Summary report: N
PHOENIX DIAMOND VALVE
MDR report key: 275838
·
Received April 29, 2000
Report
- Report Number
- 2518608-2000-00001
- Event Type
- Injury
- Date Received
- April 29, 2000
- Date of Event
- August 17, 1999
- Report Date
- April 28, 2000
- Manufacturer
- PHOENIX BIOMEDICAL CORP.
- Product Code
- JXG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PT HAD A DIAMOND VALVE IMPLANTED IN 1999, 7 WEEKS AFTER A SUBDURAL HEMATOMA. IN 1999, A SUBDURAL HEMORRHAGE WAS FOUND ON CT. BEFORE EXPLANTING THE VALVE. DR BOUND THE PERITONEAL CATHETER WITH A SUTURE TO ALLOW THE VENTRICLES TO RECOVER. THE PT'S VENTRICLES DID NOT ENLARGE. THE VALVE WAS EXPLANTED AROUND EARLY 2000.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PHOENIX DIAMOND VALVE | HYDROCEPHALIC SHUNT VALVE | JXG | PHOENIX BIOMEDICAL CORP. | NA | A08 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Required Intervention |