PUREGRAFT 850 SYSTEM 101-014-02 850/PURE-INT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-07-16 for PUREGRAFT 850 SYSTEM 101-014-02 850/PURE-INT manufactured by Puregraft Llc.

MAUDE Entry Details

Report Number3011277972-2019-00002
MDR Report Key8794513
Report SourceDISTRIBUTOR
Date Received2019-07-16
Date of Report2019-07-11
Date Mfgr Received2019-06-14
Device Manufacturer Date2018-07-01
Date Added to Maude2019-07-16
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. OLIVIA KIM
Manufacturer Street420 STEVENS AVE. SUITE 220
Manufacturer CitySOLANA BEACH CA 92075
Manufacturer CountryUS
Manufacturer Postal92075
Manufacturer Phone8583488050
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePUREGRAFT 850 SYSTEM
Generic NameSYSTEM, SUCTION, LIPOPLASTY
Product CodeMUU
Date Received2019-07-16
Model Number101-014-02
Catalog Number850/PURE-INT
Lot Number00052115
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerPUREGRAFT LLC
Manufacturer Address420 STEVENS AVE. SUITE 220 SOLANA BEACH CA 92075 US 92075


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-07-16

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