MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-24 for GENVISC 850 INJ 25/2.5 manufactured by Orthogenrx, Inc..
[181136464]
This is to report off label dosing frequency for genvisc 850 for right knee. Md is using it for weekly injections for 4 weeks (instead of 3 or 5).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093237 |
| MDR Report Key | 9750398 |
| Date Received | 2020-02-24 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-02-20 |
| Date Added to Maude | 2020-02-25 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GENVISC 850 INJ 25/2.5 |
| Generic Name | ACID, HYALURONIC, INTRAARTICULAR |
| Product Code | MOZ |
| Date Received | 2020-02-24 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHOGENRX, INC. |
| Product Code | --- |
| Date Received | 2020-02-24 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-24 |