Brand Name | PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCER |
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 | 16513125 |
MDR Text Key | 310976729 |
Report Number | 2015691-2023-11350 |
Device Sequence Number | 1 |
Product Code |
DXO
|
UDI-Device Identifier | 07460691950696 |
UDI-Public | (01)07460691950696(17)240818(11)220819(10)64453340 |
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 |
Health Professional,User Facility |
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial,Followup,Followup |
Report Date |
05/18/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/09/2023 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Model Number | PX36N |
Device Catalogue Number | PX36N |
Device Lot Number | 64453340 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 05/08/2023 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/19/2022 |
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 |
Patient Outcome(s) |
Required Intervention;
|