MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-18 for RESTYLANE SILK manufactured by Galderma Q-med.
| Report Number | 9710154-2020-00042 |
| MDR Report Key | 9849558 |
| Report Source | CONSUMER |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-18 |
| 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 | MR. RANDY RUSSELL |
| Manufacturer Street | 14501 NORTH FREEWAY |
| Manufacturer City | FORT WORTH, TX |
| Manufacturer Country | US |
| Manufacturer G1 | GALDERMA Q-MED |
| Manufacturer Street | SEMINARIEGATAN 21 |
| Manufacturer City | UPPSALA, SE-752 28 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | SE-752 28 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESTYLANE SILK |
| Generic Name | IMPLANT, DERMAL, FOR AESTHETIC USE |
| Product Code | LMH |
| Date Received | 2020-03-18 |
| Lot Number | 17059 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 |