Brand Name | TRUWAVE DISPOSABLE PRESSURE TRANSDUCER WITH 1 FOOT CABLE |
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 |
DR |
|
Manufacturer (Section G) |
EDWARDS LIFESCIENCES, DR |
parque industrial de itabo |
carr. sanchez km 18.5 |
haina, san cristobal |
DR
|
|
Manufacturer Contact |
jonathan
diaz
|
1 edwards way |
irvine, CA 92614
|
|
MDR Report Key | 16675501 |
MDR Text Key | 313561328 |
Report Number | 2015691-2023-12083 |
Device Sequence Number | 1 |
Product Code |
DXO
|
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,Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
04/04/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | PX601 |
Device Catalogue Number | PX601 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/28/2023 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
03/16/2023
|
Initial Date FDA Received | 04/04/2023 |
Was Device Evaluated by Manufacturer? |
Yes
|
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 |