FDA Adverse Event
Malfunction
Summary report: N
HERMETIC LARGE STYLE VENTRICULAR CATHETER SET
MDR report key: 375756
·
Received February 7, 2002
Report
- Report Number
- 2648988-2002-00002
- Event Type
- Malfunction
- Date Received
- February 7, 2002
- Report Date
- February 6, 2002
- Manufacturer
- HEYER SCHULTE NEUROCARE INC
- Product Code
- JXG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PHYSICIAN REPORTS HAVING PROBLEM PULLING OUT THE SYLET BECAUSE IT IS STICKING. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HERMETIC LARGE STYLE VENTRICULAR CATHETER SET | VENTRICULOSTOMY & EXTERNAL CSF DRAINAGE | JXG | HEYER SCHULTE NEUROCARE INC | * | 1010907 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |