FDA Adverse Event
Other
Summary report: N
DISTAL ATRIAL/PERITONEAL CATHETER
MDR report key: 935692
·
Received November 1, 2007
Report
- Report Number
- 3001587388-2007-00374
- Event Type
- Other
- Date Received
- November 1, 2007
- Date of Event
- September 25, 2007
- Report Date
- September 29, 2007
- Manufacturer
- SOPHYSA
- Product Code
- JXG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INCIDENT HAS BEEN REPORTED TO MANUFACTURER ON 10/16/2007. RESULTS OF ANALYSIS WILL BE DEVELOPED IN A FOLLOW-UP REPORT.
Description of Event or Problem · 1
AN INTERNAL SHUNTING KIT WAS IMPLANTED IN A PATIENT IN VENTRICULO-PERITONEAL IN 2007. AFTER SEVERAL DAYS, THE SURGEON OBSERVED A LEAKAGE OF THE PERITONEAL CATHETER. THE DOCTOR REQUEST TO CHECK THE CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DISTAL ATRIAL/PERITONEAL CATHETER | SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS | JXG | SOPHYSA | R0400 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |