Brand Name | CSF DRAINAGE SYSTEM W/BLUE STRIPE TUBING & 1-WAY |
Type of Device | N/A |
Manufacturer (Section D) |
INTEGRA NEUROSCIENCES PR |
road 402 north, km 1.2 |
road 402 north, km 1.2 |
anasco PR 00610 |
|
Manufacturer (Section G) |
INTEGRA NEUROSCIENCES PR |
road 402 north, km 1.2 |
|
anasco PR 00610 |
|
Manufacturer Contact |
rowena
bunuan
|
311 enterprise drive |
plainsboro, NJ 08536
|
6099362393
|
|
MDR Report Key | 6886313 |
MDR Text Key | 87214307 |
Report Number | 2648988-2017-00040 |
Device Sequence Number | 1 |
Product Code |
JXG
|
Combination Product (y/n) | N |
PMA/PMN Number | K972994 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
09/15/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | INS8600 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
09/15/2017 |
Initial Date FDA Received | 09/22/2017 |
Supplement Dates Manufacturer Received | 10/11/2017
|
Supplement Dates FDA Received | 11/01/2017
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|