Brand Name | STRATA® |
Type of Device | SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS |
Manufacturer (Section D) |
COVIDIEN LLC |
15 hampshire street |
mansfield 02048 |
|
Manufacturer (Section G) |
COVIDIEN LLC |
15 hampshire street |
|
mansfield 02048 |
|
Manufacturer Contact |
glen
belmer
|
9775 toledo way |
irvine, CA 92618
|
6122713209
|
|
MDR Report Key | 13113086 |
MDR Text Key | 282966218 |
Report Number | 9612501-2021-02174 |
Device Sequence Number | 1 |
Product Code |
JXG
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K042465 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
|
Type of Report
| Initial,Followup,Followup |
Report Date |
04/12/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/29/2021 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
|
Device Model Number | 42866 |
Device Catalogue Number | 42866 |
Device Lot Number | 0222024315 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 04/11/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 04/14/2021 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|