Brand Name | SUPARTZ FX |
Type of Device | ACID, HYALURONIC, INTRAARTICULAR |
Manufacturer (Section D) |
SEIKAGAKU CORPORATION |
marunouchi center building |
6-1, marunouchi 1-chome |
chiyoda-ku, tokyo 100-0 005 |
JA 100-0005 |
|
Manufacturer (Section G) |
SEIKAGAKU CORPORATION - TAKAHAGI PLANT |
258-5, aza-matsukubo, |
oaza-akahama |
takahagi-shi, ibaraki 318-0 001 |
JA
318-0001
|
|
Manufacturer Contact |
pharmacovigilance dept.
|
marunouchi center building |
6-1, marunouchi 1-chome |
chiyoda-ku, tokyo 100-0-005
|
JA
100-0005
|
|
MDR Report Key | 7327240 |
MDR Text Key | 101999666 |
Report Number | 9612392-2018-00003 |
Device Sequence Number | 1 |
Product Code |
MOZ
|
Combination Product (y/n) | N |
PMA/PMN Number | P980044 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Type of Report
| Initial |
Report Date |
01/22/2018 |
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 Model Number | 89130-4444-01 |
Device Catalogue Number | 7156-4444 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 02/22/2018 |
Event Location |
Home
|
Initial Date Manufacturer Received |
02/21/2018 |
Initial Date FDA Received | 03/09/2018 |
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;
|
|
|