FDA Adverse Event
Malfunction
Summary report: N
SHUNTASSISTANT 35
MDR report key: 1070813
·
Received July 3, 2008
Report
- Report Number
- 2916714-2008-00013
- Event Type
- Malfunction
- Date Received
- July 3, 2008
- Date of Event
- April 18, 2008
- Report Date
- June 25, 2008
- Manufacturer
- AESCULAP AG & CO. KG
- Product Code
- JXG
- PMA / PMN Number
- K011030
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE HAS BEEN FORWARDED TO MANUFACTURER FOR EVALUATION.
Description of Event or Problem · 1
SHUNT REVISION. DEVICE DID NOT SEEM TO BE WORKING. PATIENT WAS EXPERIENCING OVERDRAINING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SHUNTASSISTANT 35 | JXG | AESCULAP AG & CO. KG | FV254T | 4453843 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR |