Brand Name | PORTEX CONTINUOUS EPIDURAL |
Type of Device | ANESTHESIA CONDUCTION KIT |
Manufacturer (Section D) |
SMITHS MEDICAL ASD INC., |
10 bowman drive |
keene NH 03431 0724 |
|
Manufacturer (Section G) |
SMITHS MEDICAL ASD INC., |
10 bowman drive |
|
keene NH 03431 0724 |
|
Manufacturer Contact |
michele
seliga
|
1265 grey fox rd. |
st. paul, MN 55112
|
7633833052
|
|
MDR Report Key | 5551507 |
MDR Text Key | 41991341 |
Report Number | 2183502-2016-00736 |
Device Sequence Number | 1 |
Product Code |
CAZ
|
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 |
company representative,user f |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
04/06/2016 |
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 Catalogue Number | A4138-17 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
03/11/2016 |
Initial Date FDA Received | 04/06/2016 |
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 |
Initial
|
Patient Sequence Number | 1 |