CURE CATHETER M14

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 2020-03-03 for CURE CATHETER M14 manufactured by Cure Medical Llc.

MAUDE Entry Details

Report Number3005471919-2020-00007
MDR Report Key9781566
Report SourceCONSUMER
Date Received2020-03-03
Date of Report2020-03-03
Date of Event2020-01-15
Date Mfgr Received2020-02-03
Device Manufacturer Date2019-07-21
Date Added to Maude2020-03-03
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
Manufacturer CountryUS
Manufacturer Phone5701778
Manufacturer G1INTEGRAL MEDICAL PRODUCTS CO., LTD.
Manufacturer StreetNO. 2 DONGZE ROAD HIGH-TECH INDUSTRIAL DEVELOPME
Manufacturer CitySHAOXING, ZHEJIANG 312000
Manufacturer CountryCH
Manufacturer Postal Code312000
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCURE CATHETER
Generic NameURINARY CATHETER
Product CodeEZD
Date Received2020-03-03
Model NumberM14
Catalog NumberM14
Lot Number190721-1
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCURE MEDICAL LLC
Manufacturer Address3471 VIA LIDO, #211 NEWPORT BEACH, CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-03

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