ROSCOE MEDICAL MT2400(DQ7000)

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 2019-08-22 for ROSCOE MEDICAL MT2400(DQ7000) manufactured by Shenzhen Dongdixin Technology Co., Ltd..

MAUDE Entry Details

Report Number3005170249-2019-00001
MDR Report Key8920084
Report SourceDISTRIBUTOR
Date Received2019-08-22
Date of Report2019-08-06
Date Mfgr Received2019-08-07
Date Added to Maude2019-08-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactMRS
Manufacturer StreetBLOCK A, 5TH FLOOR, FUHUA TECH NO. 9116 BEIHUAN ROAD
Manufacturer CitySHENZHEN, 518057
Manufacturer CountryCH
Manufacturer Postal518057
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameROSCOE MEDICAL
Generic NameINTENSITY EX4 PROFESSIONAL
Product CodeGZJ
Date Received2019-08-22
Model NumberMT2400(DQ7000)
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.
Manufacturer AddressNO.3 BUILDING XILIBAIMANG XUSH INDUSTRIAL ESTATE,NANSHAN SHENZHEN, 518108 CH 518108


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-08-22

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