FDA Adverse Event
Other
Summary report: N
DIAMOND II VALVE
MDR report key: 313861
·
Received January 22, 2001
Report
- Report Number
- 2518608-2001-00002
- Event Type
- Other
- Date Received
- January 22, 2001
- Report Date
- January 19, 2001
- Manufacturer
- PHOENIX BIOMEDICAL CORP.
- Product Code
- JXG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
"4 AUGUST 2000, THE DOCTOR SAW PT AGAIN TODAY, AND NOTED THAT THE PT WAS MUCH MORE ANIMATED THAN THE PT WAS WHEN THE DOCTOR FIRST SAW THE PT. FURTHERMORE, THE PT TOLD THE DOCTOR THAT THE PT WALKS A COUPLE OF MILES A DAY. UNFORTUNATELY HOWEVER, THE PT HAS SMALL BILATERAL SUBDURAL HYGROMAS. IF THEY DON'T GET ANY BIGGER, THAT SHOULD NOT BE A MAJOR PROBLEM FOR THE PT. CONSEQUENTLY, THE DOCTOR HAS ARRANGED TO REVIEW THE PT WITH A FURTHER SCAN, IN FOUR WEEKS." AT A LATER DATE, SHUNT WAS REMOVED DUE TO BILATERAL HYGROMAS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2860 | DIAMOND II VALVE | HYDROCEPHALUS SHUNT | JXG | PHOENIX BIOMEDICAL CORP. | NA | C11 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Other |