HYDROPHILIC COATED CURE CATHETER WITH INSERTION KIT HM16UK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-06-05 for HYDROPHILIC COATED CURE CATHETER WITH INSERTION KIT HM16UK manufactured by Cure Medical Llc.

MAUDE Entry Details

Report Number3005471919-2019-00041
MDR Report Key8671867
Report SourceCONSUMER
Date Received2019-06-05
Date of Report2019-06-05
Date of Event2019-05-17
Date Mfgr Received2019-05-28
Date Added to Maude2019-06-05
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 ContactSCOTT STILES
Manufacturer Street3471 VIA LIDO, #211
Manufacturer CityNEWPORT BEACH CA 92663
Manufacturer CountryUS
Manufacturer Postal92663
Manufacturer Phone8005701778
Manufacturer G1SHAOXING FUQING HEALTH PRODUCTS CO., LTD.
Manufacturer StreetNO. 599 WUXIE ROAD SHAOXING HIGH-TECH INDUSTRIAL
Manufacturer CitySHAOXING, ZHEJIANG 312000
Manufacturer CountryCH
Manufacturer Postal Code312000
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHYDROPHILIC COATED CURE CATHETER WITH INSERTION KIT
Generic NameCATHETER CARE TRAY
Product CodeOHR
Date Received2019-06-05
Model NumberHM16UK
Catalog NumberHM16UK
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCURE MEDICAL LLC
Manufacturer Address3471 VIA LIDO, #211 NEWPORT BEACH CA 92663 US 92663


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-06-05

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