Brand Name | DIALOG+® |
Type of Device | KDI-DIALYZER, HIGH PERMEABILIT |
Manufacturer (Section D) |
B. BRAUN AVITUM AG |
schwarzenberger weg 73-79 |
melsungen, 34212 |
GM 34212 |
|
Manufacturer (Section G) |
B. BRAUN AVITUM AG |
schwarzenberger weg 73-79 |
|
melsungen, 34212 |
GM
34212
|
|
Manufacturer Contact |
jonathan
severino
|
901 marcon blvd. |
allentown, PA 18109
|
4047197287
|
|
MDR Report Key | 16372847 |
MDR Text Key | 309500622 |
Report Number | 3002879653-2023-00002 |
Device Sequence Number | 1 |
Product Code |
KDI
|
UDI-Device Identifier | 04046964285608 |
UDI-Public | (01)04046964285608 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K083460 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
02/14/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/14/2023 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 710200S |
Device Catalogue Number | 710200S |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 01/17/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/30/2015 |
Is the Device Single Use? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
|