MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-17 for SYNVISC ONE INJ 8MGML manufactured by Genzyme Corporation.
[184272383]
Report of off label dosing of synvisc one injected intraarticular into left shoulder one time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093826 |
| MDR Report Key | 9848222 |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-03-13 |
| Date Added to Maude | 2020-03-18 |
| 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 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNVISC ONE INJ 8MGML |
| Generic Name | ACID, HYALURONIC, INTRAARTICULAR |
| Product Code | MOZ |
| Date Received | 2020-03-17 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENZYME CORPORATION |
| Brand Name | 8MG/ML |
| Product Code | --- |
| Date Received | 2020-03-17 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-17 |