Brand Name | POLYFLUX 210H |
Type of Device | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM |
Manufacturer (Section D) |
GAMBRO DIALYSATOREN GMBH |
holger-crafoord-str. 26 |
hechingen 72379 |
GM 72379 |
|
Manufacturer (Section G) |
GAMBRO DIALYSATOREN GMBH |
holger-crafoord-str. 26 |
|
hechingen |
GM
|
|
Manufacturer Contact |
|
25212 w. illinois route 120 |
round lake, IL 60073
|
2242702068
|
|
MDR Report Key | 6470899 |
MDR Text Key | 72088614 |
Report Number | 9611369-2017-00030 |
Device Sequence Number | 1 |
Product Code |
KDI
|
Combination Product (y/n) | N |
Reporter Country Code | BR |
PMA/PMN Number | K043342 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
04/28/2017 |
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 Operator |
Health Professional
|
Device Expiration Date | 08/31/2019 |
Device Catalogue Number | 103580 |
Device Lot Number | 66219H01 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
03/09/2017 |
Initial Date FDA Received | 04/07/2017 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 04/28/2017
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/30/2016 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|