MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-12 for EUFLEXXA 6301182010 manufactured by Bio-technology General (israel) Ltd.
| Report Number | 3000164186-2020-00005 |
| MDR Report Key | 9823650 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-12 |
| 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 Street | 100 INTERPACE PARKWAY |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal | 07054 |
| Manufacturer G1 | BIO-TECHNOLOGY GENERAL (ISRAEL) LTD |
| Manufacturer Street | BE'ER TUVIA INDUSTRIAL ZONE POB 571 |
| Manufacturer City | KIRYAT MALACHI, 83104 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 83104 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EUFLEXXA |
| Generic Name | 1% SODIUM HYALURONATE |
| Product Code | MOZ |
| Date Received | 2020-03-12 |
| Catalog Number | 6301182010 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO-TECHNOLOGY GENERAL (ISRAEL) LTD |
| Manufacturer Address | BEE'ER TUVIA INDUSTRIAL ZONE POB 571 KIRYAT MALACHI, 83104 IS 83104 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-03-12 |