Brand Name | GEL-ONE |
Type of Device | ACID, HYALURONIC, INTRAARTICULAR |
Manufacturer (Section D) |
SEIKAGAKU CORP., TAKAHAGI PLANT |
|
|
MDR Report Key | 8523219 |
MDR Text Key | 142461263 |
Report Number | MW5085941 |
Device Sequence Number | 1 |
Product Code |
MOZ
|
UDI-Device Identifier | 87541030091 |
UDI-Public | 87541-0300-91 |
Combination Product (y/n) | Y |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Pharmacist
|
Type of Report
| Initial |
Report Date |
04/14/2019 |
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 |
No Information
|
Device Expiration Date | 06/18/2019 |
Device Lot Number | 0017Z20G |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 04/16/2019 |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
|
Patient Age | 45 YR |
|
|