Brand Name | PRESSURE MONITORING KIT |
Type of Device | TRANSDUCER, PRESSURE, CATHETER TIP |
Manufacturer (Section D) |
EDWARDS LIFESCIENCES DR |
parque industrial de itabo |
carr. sanchez km 18.5 |
haina, san cristobal |
|
Manufacturer (Section G) |
EDWARDS LIFESCIENCES DR |
parque industrial de itabo |
carr. sanchez km 18.5 |
haina, san cristobal |
|
Manufacturer Contact |
jonathan
diaz
|
1 edwards way |
irvine, CA 92614
|
|
MDR Report Key | 14059328 |
MDR Text Key | 292482192 |
Report Number | 2015691-2022-04936 |
Device Sequence Number | 1 |
Product Code |
DXO
|
UDI-Device Identifier | 07460691955080 |
UDI-Public | (01)07460691955080(17)230626(11)210626(10)63872072 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K925638 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
04/28/2022 |
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 Expiration Date | 06/26/2023 |
Device Model Number | PXVMP160 |
Device Catalogue Number | PXVMP160 |
Device Lot Number | 63872072 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
03/18/2022
|
Initial Date FDA Received | 04/08/2022 |
Supplement Dates Manufacturer Received | 04/25/2022
|
Supplement Dates FDA Received | 04/28/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/26/2021 |
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 |