FDA Adverse Event
Malfunction
Summary report: N
INS-8301 WITHOUT THE LOWER/PROXIMAL CSF ACCESS P
MDR report key: 2060837
·
Received March 11, 2011
Report
- Report Number
- 2648988-2011-00008
- Event Type
- Malfunction
- Date Received
- March 11, 2011
- Report Date
- March 11, 2011
- Manufacturer
- INTEGRA, ANASCO
- Product Code
- JXG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.
Description of Event or Problem · 1
AN INS-8301 WITHOUT THE LOWER/PROXIMAL (CSF) CEREBROSPINAL FLUID ACCESS WAS REPORTED TO HAVE DRAINED (CSF) TOWARDS THE PATIENT'S HEAD. THE PATIENT DID NOT INCUR AN INJURY AS A RESULT OF THIS EVENT HOWEVER, ANOTHER DRAIN WAS REQUIRED TO REPLACE THE DEFECTIVE ONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INS-8301 WITHOUT THE LOWER/PROXIMAL CSF ACCESS P | NA | JXG | INTEGRA, ANASCO | 1104291 OR 1001474 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |