FDA Adverse Event
Injury
Summary report: N
PUDENZ VENTRICULAR CATHETER
MDR report key: 228231
·
Received June 22, 1999
Report
- Report Number
- 2132740-1999-00014
- Event Type
- Injury
- Date Received
- June 22, 1999
- Report Date
- May 24, 1999
- Manufacturer
- HEYER-SCHULTE NEUROCARE, INC
- Product Code
- HCA
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CUSTOMER CLAIMS: "REPORTED THAT SHUNT WAS REMOVED FROM A NINE MONTH-OLD BABY DUE TO ALLEGED CONNECTOR OF VALVE BROKEN FROM THE ROOT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUDENZ VENTRICULAR CATHETER Implant | VENTRICULAR CATHETER | HCA | HEYER-SCHULTE NEUROCARE, INC | NL850-1224 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |