D
Patient 1
USER FACILITY REPORT# 0000230038-1999-0017 REPORTS CODMAN ICP TRANSDUCER PLACED IN 1999. THREE DAYS LATER, NO WAVEFORM OR ICP READINGS. CATHETER WAS REMOVED AND WAS FOUND TO HAVE THINNED SEGMENT NEAR MIDDLE OF THE CATHETER.
MAUDE MDR 249415
- MDR report key
- 249415
- Report number
- 1219655-1999-00176
- Event key
- 0
- Event type
- 3
- Date of event
- 1999-09-24
- Date received
- 1999-11-11
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 0
- Initial report to FDA
- 0
- Event location
- 0
Manufacturer Contact#
- Contact
- MATTHEW KING
- Address
- 325 PARAMOUNT DR RAYNHAM MA 02767 US
- Phone
- 508-508-5080
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NEUROMONITOR BASIC KIT | INTRACRANIAL PRESSURE MONITOR | JOHNSON & JOHNSON PROFESSIONAL, INC. | GWM | NA | 82-6631 | K914479 | Y | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 1999-11-11 | 0 | 1. R |