FDA Adverse Event
Other
Summary report: N
INTRACRANIAL KIT 110-4BT
MDR report key: 1202752
·
Received October 9, 2008
Report
- Report Number
- 2023988-2008-00037
- Event Type
- Other
- Date Received
- October 9, 2008
- Date of Event
- September 1, 2008
- Report Date
- October 9, 2008
- Manufacturer
- INTEGRA NEUROSCIENCES
- Product Code
- GWM
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.
Description of Event or Problem · 1
THE DISTRIBUTOR REPORTED ON BEHALF OF THE USER FACILITY, THAT THE CATHETER WAS DEFECTIVE. A NEW CATHETER WAS USED TO REPLACE THE DEFECTIVE CATHETER. THE MONITOR SCREEN SHOWED "CHECK CATHETER CONNECTION" DURING THE MALFUNCTION. THE CATHETER DID NOT CAUSE ANY PROBLEM TO THE PT. THE PT HAD A DIAGNOSIS OF BRAIN TRAUMA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTRACRANIAL KIT 110-4BT | INTERCRANIAL PRESS/TEMP MONITORING KIT | GWM | INTEGRA NEUROSCIENCES | 110-4BT | 107444 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |