FDA Adverse Event Other Summary report: N

PHOENIX CRX VALVE

MDR report key: 304244 · Received November 6, 2000

Report

Report Number
2518608-2000-00006
Event Type
Other
Date Received
November 6, 2000
Report Date
November 6, 2000
Manufacturer
PHOENIX BIOMEDICAL CORP
Product Code
JXG
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
TU
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

VALVE FLOWED PROPERLY BEFORE IMPLANTATION, THEN AFTER IMPLANTATION IT NO LONGER HAD FLOW. SHUNT REVISED AND PT OK.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PHOENIX CRX VALVE HYDROCEPHALIC SHUNT VALVE JXG PHOENIX BIOMEDICAL CORP NA G005

Patients

Seq Age Sex Outcome Treatment
1 * Other