FDA Adverse Event
Injury
Summary report: N
CODMAN EXTERNAL DRAINAGE SYSTEM III
MDR report key: 1002533
·
Received February 26, 2008
Report
- Report Number
- 1226348-2008-00038
- Event Type
- Injury
- Date Received
- February 26, 2008
- Manufacturer
- CODMAN & SHURTLEFF, INC./MEDOS S.A
- Product Code
- JXG
- PMA / PMN Number
- K954021
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CODMAN HAS RECEIVED THE DEVICE FOR INVESTIGATION. IT IS UNCLEAR AT THIS POINT WHAT THE SURGEON REPLACED. IT IS PRESUMED THAT THE CATHETER WAS CHANGED. UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.
Description of Event or Problem · 1
CUSTOMER REPORTS THAT "SYSTEM BECAME OCCLUDED AND HAD TO BE REPLACED. SURGEON BELIEVES THAT AIR ENTERED INTO THE SYSTEM OR THERE IS A CRACK IN SOME PLACE OF THE SYSTEM."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CODMAN EXTERNAL DRAINAGE SYSTEM III | SHUNT, CENTRAL NERVOUS SYSTEM & COMPS | JXG | CODMAN & SHURTLEFF, INC./MEDOS S.A | NA | CHMBYV |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK YR | Required Intervention |