MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-19 for SYNVISC ONE INJ 8MG/ML manufactured by Genzyme Corporation.
[184479995]
Patient reports that he was administered synvisc-one on (b)(6) 2020. On (b)(6) 2020 he had a fall and a second fall shortly after. He went to the emergency room for evaluation. No breaks were observed but his mobility and ability to walk have become significantly compromised. Patient has reached out to the administering doctor and is waiting for a follow-up call.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093847 |
| MDR Report Key | 9859686 |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-03-11 |
| Date Added to Maude | 2020-03-20 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNVISC ONE INJ 8MG/ML |
| Generic Name | ACID, HYALURONIC, INTRA ARTICULAR |
| Product Code | MOZ |
| Date Received | 2020-03-19 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENZYME CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-19 |