FDA Adverse Event
Injury
Summary report: N
HAKIM VALVE
MDR report key: 2911610
·
Received January 11, 2013
Report
- Report Number
- 1226348-2013-10855
- Event Type
- Injury
- Date Received
- January 11, 2013
- Date of Event
- December 11, 2012
- Manufacturer
- CODMAN & SHURTLEFF, INC
- Product Code
- JXG
- PMA / PMN Number
- PK974739
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.
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. (B)(4): DEVICE NOT RETURNED.
Description of Event or Problem · 1
AFFILIATE REPORTED THAT UNDER DRAINAGE WAS NOTED AND AS A RESULT THE DEVICE WAS REVISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 16381 | HAKIM VALVE | SHUNT, CENTRAL NERVOUS SYSTEM & COMPS | JXG | CODMAN & SHURTLEFF, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Required Intervention |