RADIESSE INJECTABLE IMPLANT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-23 for RADIESSE INJECTABLE IMPLANT manufactured by Merz North America, Inc..

MAUDE Entry Details

Report Number3013840437-2020-00036
MDR Report Key9868129
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-23
Date of Report2020-03-23
Date Mfgr Received2020-02-25
Date Added to Maude2020-03-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactPRODUCT SAFETY
Manufacturer Street6501 SIX FORKS ROAD
Manufacturer CityRALEIGH, NC
Manufacturer CountryUS
Manufacturer Phone5828000
Manufacturer G1MERZ NORTH AMERICA, INC.
Manufacturer Street4133 COURTNEY STREET SUITE 10
Manufacturer CityFRANKSVILLE, WI
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRADIESSE INJECTABLE IMPLANT
Generic NameIMPLANT, DERMAL, FOR AESTHETIC USE
Product CodeLMH
Date Received2020-03-23
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMERZ NORTH AMERICA, INC.
Manufacturer Address4133 COURTNEY STREET SUITE 10 FRANKSVILLE, WI US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-23

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