Brand Name | SUPARTZ |
Type of Device | HYALURONIC ACID |
Manufacturer (Section D) |
SEIKAGAKU CORPORATION |
6-1, marunouchi 1-chome, |
chiyoda-ku, tokyo, japan |
JA |
|
MDR Report Key | 16080620 |
MDR Text Key | 306452637 |
Report Number | 3009595577-2022-00006 |
Device Sequence Number | 1 |
Product Code |
MOZ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
12/07/2022,12/05/2022 |
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 Operator |
Health Professional
|
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 12/05/2022 |
Event Location |
Outpatient Treatment Facility
|
Date Report to Manufacturer | 12/07/2022 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 12/30/2022 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Life Threatening;
Required Intervention;
|
|
|