MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-05 for DUROLANE 1082020 manufactured by Q-med Ab.
| Report Number | 3009595577-2020-00002 |
| MDR Report Key | 9795333 |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-02-04 |
| Date Facility Aware | 2020-02-04 |
| Report Date | 2020-03-05 |
| Date Reported to FDA | 2020-03-05 |
| Date Added to Maude | 2020-03-05 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | DUROLANE |
| Generic Name | HYALURONIC ACID |
| Product Code | MOZ |
| Date Received | 2020-03-05 |
| Catalog Number | 1082020 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | Q-MED AB |
| Manufacturer Address | SEMINARIEGATAN 21 UPPSALA, SE-752 28 SW SE-752 28, |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-05 |