MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-18 for RESTYLANE REFYNE manufactured by Galderma Q-med.
| Report Number | 1000118068-2020-00017 |
| MDR Report Key | 9849539 |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date Facility Aware | 2020-03-03 |
| Report Date | 2020-03-18 |
| Date Reported to FDA | 2020-03-18 |
| Date Reported to Mfgr | 2020-03-03 |
| Date Added to Maude | 2020-03-18 |
| 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 | RESTYLANE REFYNE |
| Generic Name | IMPLANT, DERMAL, FOR AESTHETIC USE |
| Product Code | LMH |
| Date Received | 2020-03-18 |
| Lot Number | 16918 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GALDERMA Q-MED |
| Manufacturer Address | SEMINARIEGATAN 21 UPPSALA, SE-752 28 SW SE-752 28 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-18 |