Brand Name | PORTEX KITS OTHER |
Type of Device | NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER |
Manufacturer (Section D) |
SMITHS MEDICAL INTERNATIONAL, LTD. |
olomoucka 306 |
hranice 1, mesto 753 0 1 |
EZ 753 01 |
|
Manufacturer (Section G) |
SMITHS MEDICAL INTERNATIONAL, LTD. |
olomoucka 306 |
|
hranice 1, mesto 753 0 1 |
EZ
753 01
|
|
Manufacturer Contact |
jim
vegel
|
6000 nathan lane north |
akasaka, minato-ku, tokyo |
minneapolis, MN 55442
|
|
MDR Report Key | 15398007 |
MDR Text Key | 305256906 |
Report Number | 3012307300-2022-18600 |
Device Sequence Number | 1 |
Product Code |
BSP
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K171968 |
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 |
09/11/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/11/2022 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | EPX1305/118DJP |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/06/2020 |
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 02/28/2020 |
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 |
|
|