RESTYLANE DEFYNE

MAUDE Adverse Event Report

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 DEFYNE manufactured by Galderma Q-med.

MAUDE Entry Details

Report Number9710154-2020-00039
MDR Report Key9849486
Report SourceCONSUMER
Date Received2020-03-18
Date of Report2020-03-18
Date Mfgr Received2020-03-04
Date Added to Maude2020-03-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. RANDY RUSSELL
Manufacturer Street14501 NORTH FREEWAY
Manufacturer CityFORT WORTH, TX
Manufacturer CountryUS
Manufacturer G1GALDERMA Q-MED
Manufacturer StreetSEMINARIEGATAN 21
Manufacturer CityUPPSALA, SE-752 28
Manufacturer CountrySW
Manufacturer Postal CodeSE-752 28
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRESTYLANE DEFYNE
Generic NameIMPLANT, DERMAL, FOR AESTHETIC USE
Product CodeLMH
Date Received2020-03-18
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerGALDERMA Q-MED
Manufacturer AddressSEMINARIEGATAN 21 UPPSALA, SE-752 28 SW SE-752 28


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-18

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