OSCAR 2, 250D 99-0233-40

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 2020-02-19 for OSCAR 2, 250D 99-0233-40 manufactured by Suntech Medical, Inc..

MAUDE Entry Details

Report Number1036863-2020-00003
MDR Report Key9730018
Report SourceDISTRIBUTOR
Date Received2020-02-19
Date of Report2020-01-23
Date of Event2020-01-06
Date Mfgr Received2020-01-23
Device Manufacturer Date2019-09-27
Date Added to Maude2020-02-19
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 ContactMR. CHARLES SETZER
Manufacturer Street507 AIRPORT BLVD, SUITE 117
Manufacturer CityMORRISVILLE, NC
Manufacturer CountryUS
Manufacturer G1SUNTECH MEDICAL, INC.
Manufacturer Street507 AIRPORT BLVD, SUITE 117
Manufacturer CityMORRISVILLE, NC
Manufacturer CountryUS
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction Number84531
Event Type3
Type of Report3

Device Details

Brand NameOSCAR 2, 250D
Generic NameSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Product CodeDXN
Date Received2020-02-19
Model Number250D
Catalog Number99-0233-40
Device Availability*
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSUNTECH MEDICAL, INC.
Manufacturer Address507 AIRPORT BLVD, SUITE 117 MORRISVILLE, NC US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.