Brand Name | PORTEX SPINAL SINGLE SHOT TRAYS |
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 OH 03431 0724 |
|
Manufacturer Contact |
dave
halverson
|
1265 grey fox road |
st. paul, MN 55112
|
7633833310
|
|
MDR Report Key | 7891757 |
MDR Text Key | 120821028 |
Report Number | 3012307300-2018-03725 |
Device Sequence Number | 1 |
Product Code |
CAZ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
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 |
09/19/2018 |
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 |
No Information
|
Device Expiration Date | 10/01/2020 |
Device Catalogue Number | NEPI-49661-25 |
Device Lot Number | 3624023 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/04/2018 |
Initial Date Manufacturer Received |
08/21/2018 |
Initial Date FDA Received | 09/19/2018 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 05/29/2018 |
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;
|