Brand Name | OPTIFLUX 180NRE DIALYZER FINISHED ASSY. |
Type of Device | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM |
Manufacturer (Section D) |
OGDEN MANUFACTURING PLANT |
director, site quality |
475 west 13th street |
ogden UT 84404 |
|
Manufacturer (Section G) |
OGDEN MANUFACTURING PLANT |
director, site quality |
475 west 13th street |
ogden UT 84404 |
|
Manufacturer Contact |
jessica
trujillo
|
920 winter st |
waltham, MA 02451
|
6174175172
|
|
MDR Report Key | 19218196 |
MDR Text Key | 341483446 |
Report Number | 0001713747-2024-00345 |
Device Sequence Number | 1 |
Product Code |
KDI
|
UDI-Device Identifier | 00840861100156 |
UDI-Public | 00840861100156 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K162488 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Nurse
|
Type of Report
| Initial,Followup |
Report Date |
05/09/2024 |
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 Catalogue Number | 0500318E |
Device Lot Number | 24AU07012 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Device Age | MO |
Initial Date Manufacturer Received |
04/29/2024
|
Initial Date FDA Received | 04/30/2024 |
Supplement Dates Manufacturer Received | 05/09/2024
|
Supplement Dates FDA Received | 05/09/2024
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/14/2024 |
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 |
Treatment | FRESENIUS 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES |
Patient Age | 48 YR |
Patient Sex | Male |
Patient Weight | 74 KG |