Brand Name | PORTEX® COMBINED SPINAL EPIDURAL SYSTEM |
Type of Device | ANESTHESIA CONDUCTION KIT |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
6000 nathan lane north |
minneapolis MN 55442 |
|
Manufacturer (Section G) |
SMITHS MEDICAL NORTH AMERICA |
10 bowman drive |
|
keene NH 03431 0724 |
|
Manufacturer Contact |
lisa
perz
|
6000 nathan lane north |
minneapolis, MN 55442
|
7633833074
|
|
MDR Report Key | 6354651 |
MDR Text Key | 68209062 |
Report Number | 3012307300-2017-00634 |
Device Sequence Number | 1 |
Product Code |
CAZ
|
UDI-Device Identifier | 30351688058007 |
UDI-Public | 30351688058007 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K965017 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
02/17/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 05/01/2018 |
Device Catalogue Number | A2693-17/27 |
Device Lot Number | 3318736 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
02/17/2017 |
Initial Date FDA Received | 02/23/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/14/2016 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
Required Intervention;
|
Patient Age | 44 YR |