Brand Name | LIPOSORBER LA-15 SYSTEM |
Type of Device | LIPOPROTEIN, LOW DENSITY, REMOVAL |
Manufacturer (Section D) |
KANEKA CORPORETION |
nakanoshima |
kita-ku |
osaka, 530-8 288 |
JA 530-8288 |
|
Manufacturer (Section G) |
KANEKA CORPORATION OSAKA PLANT |
5-1-1 torikai-nishi |
|
settu-city, osaka 56600 72 |
JA
5660072
|
|
Manufacturer Contact |
joji
sengoku
|
akasaka 1-12-32 |
minato-ku |
tokyo 10711-52
|
JA
1071152
|
|
MDR Report Key | 15822448 |
MDR Text Key | 303902856 |
Report Number | 3002808904-2022-00015 |
Device Sequence Number | 1 |
Product Code |
MMY
|
UDI-Device Identifier | 14993478010110 |
UDI-Public | 14993478010110 |
Combination Product (y/n) | N |
Reporter Country Code | IT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility,Distributor |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
10/21/2022 |
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 Model Number | LA-15 |
Device Catalogue Number | N/A |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/21/2022
|
Initial Date FDA Received | 11/18/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |
Patient Outcome(s) |
Other;
|
Patient Age | 32 YR |
Patient Sex | Female |
Patient Weight | 63 KG |
Patient Ethnicity | Non Hispanic |
Patient Race | White |