FDA Adverse Event
Injury
Summary report: N
CHPV CYL W/LG RR NU120CM DIST
MDR report key: 1893006
·
Received October 28, 2010
Report
- Report Number
- 1226348-2010-00349
- Event Type
- Injury
- Date Received
- October 28, 2010
- Manufacturer
- CODMAN & SHURTLEFF, INC. MEDOS S.A.
- Product Code
- JXG
- PMA / PMN Number
- K974739
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.
Description of Event or Problem · 1
SALES REP REPORTED THAT: "VALVE WAS REVISED". NO OTHER DETAILS WERE AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CHPV CYL W/LG RR NU120CM DIST | SHUNT, CENTRAL NERVOUS SYSTEM & COMPS | JXG | CODMAN & SHURTLEFF, INC. MEDOS S.A. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |