MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-25 for ORTHOVISC 630-254 manufactured by Anika Therapeutics Inc.
[187925732]
It was reported by the patient assistance group that patient stated she is waiting for a knee replacement and needs to use the orthovisc. She got a double blood clot and had to go to the hospital where she received pharmacological treatment. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007093114-2020-00005 |
| MDR Report Key | 9881114 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-03-25 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | REBECCA OBENG |
| Manufacturer Street | 32 WIGGINS AVE |
| Manufacturer City | BEDFORD, |
| Manufacturer Country | US |
| Manufacturer Phone | 4579000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHOVISC |
| Generic Name | SODIUM HYALURONATE FOR INTRA-ARTICULAR INJECTION |
| Product Code | MOZ |
| Date Received | 2020-03-25 |
| Model Number | 630-254 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANIKA THERAPEUTICS INC |
| Manufacturer Address | 32 WIGGINS AVE BEDFORD, MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-25 |