FDA Adverse Event
Injury
Summary report: N
CODMAN BACTISEAL EVD CATHETER
MDR report key: 1425485
·
Received July 30, 2009
Report
- Report Number
- 1226348-2009-00200
- Event Type
- Injury
- Date Received
- July 30, 2009
- Manufacturer
- CODMAN & SHURTLEFF, INC. / MEDOS
- Product Code
- JXG
- PMA / PMN Number
- K021653
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CONSIDERED CLOSED.
Description of Event or Problem · 1
REP EXPLAINED THAT THE CLINICAL NURSE SPECIALIST EXPLAINED THAT BLEEDING WAS NOTICED IN THE VENTRICLES OF THE PATIENT UPON REMOVAL OF THE CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CODMAN BACTISEAL EVD CATHETER | SHUNT, CENTRAL NERVOUS SYSTEM & COMPS | JXG | CODMAN & SHURTLEFF, INC. / MEDOS | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |