FDA Adverse Event
Injury
Summary report: N
CODMAN MICROSENSOR
MDR report key: 1083460
·
Received July 28, 2008
Report
- Report Number
- MW5007816
- Event Type
- Injury
- Date Received
- July 28, 2008
- Date of Event
- July 6, 2008
- Report Date
- July 28, 2008
- Manufacturer
- JOHNSON AND JOHNSON
- Product Code
- GWM
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
IN 2008 AN MRI OF THE BRAIN WAS PERFORMED. WHEN HE RETURNED TO THE ICU IT WAS NOTED THE ICP MONITOR WAS NO LONGER WORKING. THE TIP OF THE CATHETER, 1 CM, WAS NOTED TO DAMAGED DUE TO THE MRI. THE PT SUFFERED NO ADVERSE EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CODMAN MICROSENSOR | CODMAN | GWM | JOHNSON AND JOHNSON | 826631 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 YR | Hospitalization |