Brand Name | MONOVISC 88MG/4ML |
Type of Device | ACID, HYALURONIC, INTRAARTICULAR |
Manufacturer (Section D) |
DEPUY MITEK / ANIKA THERAPEUTIC, INC. |
|
|
MDR Report Key | 12348464 |
MDR Text Key | 267721999 |
Report Number | MW5103374 |
Device Sequence Number | 1 |
Product Code |
MOZ
|
UDI-Device Identifier | 59676082001 |
UDI-Public | 59676082001 |
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 |
08/17/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/19/2021 |
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
|
Was Device Evaluated by Manufacturer? |
No Information
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
|
|
|