THE CELLFINA SYSTEM CK-1 5036030

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 2019-07-24 for THE CELLFINA SYSTEM CK-1 5036030 manufactured by Ulthera, Inc., Merz Device Innovation Center.

MAUDE Entry Details

Report Number3006560326-2019-00014
MDR Report Key8822589
Report SourceHEALTH PROFESSIONAL
Date Received2019-07-24
Date of Report2019-06-28
Date of Event2019-02-09
Date Mfgr Received2019-06-28
Device Manufacturer Date2018-01-26
Date Added to Maude2019-07-24
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 ContactMS. JESSICA CIOTTI
Manufacturer Street1840 SOUTH STAPLEY DRIVE SUITE 200
Manufacturer CityMESA AZ 85204
Manufacturer CountryUS
Manufacturer Postal85204
Manufacturer Phone4808288875
Manufacturer G1ULTHERA, INC., MERZ DEVICE INNOVATION CENTER
Manufacturer Street1840 SOUTH STAPLEY DRIVE SUITE 200
Manufacturer CityMESA AZ 85204
Manufacturer CountryUS
Manufacturer Postal Code85204
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTHE CELLFINA SYSTEM
Generic NameCELLFINA SYSTEM
Product CodeOUP
Date Received2019-07-24
Model NumberCK-1
Catalog Number5036030
Lot Number2018011204
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerULTHERA, INC., MERZ DEVICE INNOVATION CENTER
Manufacturer Address1840 SOUTH STAPLEY DRIVE SUITE 200 MESA AZ 85204 US 85204


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-07-24

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