MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-05 for SYNVISC ONE manufactured by Genzyme Corporation(ridgefield).
| Report Number | 2246315-2020-00034 |
| MDR Report Key | 9793449 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-04 |
| Date of Event | 2019-12-05 |
| Date Added to Maude | 2020-03-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | DR. HEATHER SCHIAPPACASSE |
| Manufacturer Street | 55 CORPORATE DRIVE, MS 55B-220 A |
| Manufacturer City | BRIDGEWATER 08807 |
| Manufacturer Country | US |
| Manufacturer Postal | 08807 |
| Manufacturer G1 | GENZYME CORPORATION(RIDGEFIELD) |
| Manufacturer Street | 1125 PLEASANTVIEW TERRACE |
| Manufacturer City | RIDGEFIELD 07657 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07657 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNVISC ONE |
| Generic Name | MOZ |
| Product Code | MOZ |
| Date Received | 2020-03-05 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENZYME CORPORATION(RIDGEFIELD) |
| Manufacturer Address | 1125 PLEASANTVIEW TERRACE RIDGEFIELD 07657 US 07657 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-05 |