FDA Adverse Event
Malfunction
Summary report: N
PROGAV W/SHUNTASSIST .25 + DIST. CATH
MDR report key: 1070816
·
Received July 3, 2008
Report
- Report Number
- 2916714-2008-00014
- Event Type
- Malfunction
- Date Received
- July 3, 2008
- Date of Event
- May 14, 2008
- Report Date
- June 26, 2008
- Manufacturer
- AESCULAP AG & CO, KG
- Product Code
- JXG
- PMA / PMN Number
- K062009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE HAS BEEN FORWARDED TO MANUFACTURER FOR EVALUATION.
Description of Event or Problem · 1
PROGAV VALVE WOULD HAVE REPROGRAM BY ITSELF. BREAKING SYSTEM MIGHT HAVE BEEN DAMAGED. PUT IN A NEW VALVE. DR. MCLANAHAN CUT THE SHUNT ASSISTANT THAT WAS ATTACHED TO THE PROGRAV AND LEFT IT IN THE PATIENT AND ADDED A CODMAN VALVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGAV W/SHUNTASSIST .25 + DIST. CATH | JXG | AESCULAP AG & CO, KG | FV421T |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Other |