Brand Name | PORTEX EPIDURAL CUSTOM CONTINUOUS TRAYS |
Type of Device | ANESTHESIA, CONDUCTION KIT |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
10 bowman dr. |
keene NH 03431 |
|
Manufacturer (Section G) |
SMITHS MEDICAL ASD, INC. |
10 bowman dr. |
|
keene NH 03431 |
|
Manufacturer Contact |
jim
vegel
|
6000 nathan lane north |
akasaka, minato-ku, tokyo |
minneapolis, MN 55442
|
|
MDR Report Key | 15330066 |
MDR Text Key | 305376605 |
Report Number | 3012307300-2022-17108 |
Device Sequence Number | 1 |
Product Code |
CAZ
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
08/31/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/31/2022 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/23/2020 |
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 10/20/2020 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |