RESTYLANE REFYNE

MAUDE Adverse Event Report

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.

MAUDE Entry Details

Report Number1000118068-2020-00017
MDR Report Key9849539
Date Received2020-03-18
Date of Report2020-03-18
Date Facility Aware2020-03-03
Report Date2020-03-18
Date Reported to FDA2020-03-18
Date Reported to Mfgr2020-03-03
Date Added to Maude2020-03-18
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRESTYLANE REFYNE
Generic NameIMPLANT, DERMAL, FOR AESTHETIC USE
Product CodeLMH
Date Received2020-03-18
Lot Number16918
Device AvailabilityN
Device Eval'ed by Mfgr*
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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