Brand Name | MEDEX PRESSURE MONITORING MEDEX TRANSTAR KITS |
Type of Device | PROBE, BLOOD-FLOW, EXTRAVASCULAR |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
6250 shier rings road |
dublin OH 43016 |
|
Manufacturer (Section G) |
SMITHS MEDICAL ASD, INC. |
6250 shier rings road |
|
dublin OH 43016 |
|
Manufacturer Contact |
jim
vegel
|
6000 nathan lane north |
minneapolis, MN 55442
|
|
MDR Report Key | 15395072 |
MDR Text Key | 302770507 |
Report Number | 3012307300-2022-18362 |
Device Sequence Number | 1 |
Product Code |
DPT
|
UDI-Device Identifier | 10351688503992 |
UDI-Public | 10351688503992 |
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K942377 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
09/09/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/09/2022 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 06/08/2023 |
Device Model Number | MX9505T |
Device Catalogue Number | MX9505T |
Device Lot Number | 4002470 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 04/27/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/30/2020 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Age | 55 YR |
Patient Sex | Female |