Brand Name | EUFLEXXA, 10 MG/ML |
Type of Device | ACID, HYALURONIC, INTRAARTICULAR |
Manufacturer (Section D) |
FERRING / BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. |
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|
MDR Report Key | 11019174 |
MDR Text Key | 222082467 |
Report Number | MW5098398 |
Device Sequence Number | 1 |
Product Code |
MOZ
|
UDI-Device Identifier | 55566410001 |
UDI-Public | 55566410001 |
Combination Product (y/n) | Y |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
12/11/2020 |
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 | 03/28/2021 |
Device Lot Number | R13626A |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 12/15/2020 |
Was Device Evaluated by Manufacturer? |
No Information
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
|
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