Brand Name | GEL-ONE |
Type of Device | ACID, HYALURONIC INTRAARTICULAR |
Manufacturer (Section D) |
SEIKAGAKU CORP., TAKAHAGI PLANT |
|
|
MDR Report Key | 7650311 |
MDR Text Key | 112909741 |
Report Number | MW5078158 |
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 |
Voluntary
|
Reporter Occupation |
Pharmacist
|
Type of Report
| Initial |
Report Date |
06/26/2018 |
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 |
No Information
|
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 06/28/2018 |
Was Device Evaluated by Manufacturer? |
No Information
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
|
Patient Age | 59 YR |
|
|