FDA Adverse Event
Injury
Summary report: N
CODMAN BACTISEAL VENTRICULAR CATHETER
MDR report key: 508628
·
Received January 28, 2004
Report
- Report Number
- 1226348-2004-00019
- Event Type
- Injury
- Date Received
- January 28, 2004
- Report Date
- January 7, 2004
- Manufacturer
- CODMAN & SHURTLEFF, INC./MEDOS S.A.
- Product Code
- JXG
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
GRAM POSITIVE INFECTION OF STAPH AUREUS WAS ISOLATED FROM A PT THREE DAYS FOLLOWING IMPLANTATION OF A BACTISEAL CATHETER. THE ORGANISM IDENTIFIED AT THE HOSP IN 12/2003 AS A "RARE STRAIN." EXPLANT OF THE DEVICE WAS TO BE SCHEDULED FOR 2004 BUT IT IS NOT KNOWN IF THAT TOOK PLACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CODMAN BACTISEAL VENTRICULAR CATHETER | SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS | JXG | CODMAN & SHURTLEFF, INC./MEDOS S.A. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |