Brand Name | GEL-ONE PFS 30MG/3ML |
Type of Device | ACID, HYALURONIC, INTRAARTICULAR |
Manufacturer (Section D) |
SEIKAGAKU CORPORATION, TAKAHAGI PLANT |
|
|
MDR Report Key | 18205073 |
MDR Text Key | 329136165 |
Report Number | MW5148475 |
Device Sequence Number | 1 |
Product Code |
MOZ
|
UDI-Device Identifier | 50016095711 |
UDI-Public | 50016095711 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
11/21/2023 |
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
|
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 11/22/2023 |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
|
Patient Age | 75 YR |
Patient Sex | Male |
|
|