Brand Name | PHOENIX |
Type of Device | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM |
Manufacturer (Section D) |
BAXTER HEALTHCARE - MEDOLLA MODENA MONITORS |
medolla modena |
|
Manufacturer (Section G) |
BAXTER HEALTHCARE - MEDOLLA MODENA MONITORS |
via modenese, 66 |
|
medolla modena 41036 |
IT
41036
|
|
Manufacturer Contact |
|
25212 w. illinois route 120 |
round lake, IL 60073
|
2242702068
|
|
MDR Report Key | 8526849 |
MDR Text Key | 142336413 |
Report Number | 9616240-2019-00003 |
Device Sequence Number | 1 |
Product Code |
KDI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K103832 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
|
Type of Report
| Initial,Followup |
Report Date |
04/18/2019,05/17/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/18/2019 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
|
Device Catalogue Number | 103453 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/28/2019 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 04/18/2019 |
Distributor Facility Aware Date | 03/25/2019 |
Event Location |
Other
|
Date Report to Manufacturer | 04/18/2019 |
Date Manufacturer Received | 04/19/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Treatment Data |
Date Received: 04/18/2019 Patient Sequence Number: 1 |
|
|