Brand Name | PORTEX® EPIDURAL MINIPACKS |
Type of Device | ANESTHESIA CONDUCTION KIT |
Manufacturer (Section D) |
SMITHS MEDICAL ASD; INC. |
6000 nathan lane n |
minneapolis, MN 55442 |
|
Manufacturer (Section G) |
SMITHS MEDICAL CZECH REPUBLIC A. S. |
olomouck[?] 306, |
hranice 1 |
mesto, hranice 753 0 1 |
EZ
753 01
|
|
Manufacturer Contact |
dave
halverson
|
6000 nathan lane n |
minneapolis,, MN 55442
|
7633833310
|
|
MDR Report Key | 7706280 |
MDR Text Key | 114570263 |
Report Number | 3012307300-2018-02891 |
Device Sequence Number | 1 |
Product Code |
CAZ
|
Combination Product (y/n) | N |
Reporter Country Code | RS |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign,user faci |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
07/20/2018 |
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 Expiration Date | 07/25/2022 |
Device Catalogue Number | 100/391/128CZ |
Device Lot Number | 3470048 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
07/02/2018 |
Initial Date FDA Received | 07/20/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/11/2017 |
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) |
Required Intervention;
|