ENDOCLEAR RESTORE EC-100-01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-10-02 for ENDOCLEAR RESTORE EC-100-01 manufactured by Avanos Medical, Inc..

MAUDE Entry Details

Report Number3011270181-2019-00043
MDR Report Key9148215
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2019-10-02
Date of Report2019-09-24
Date of Event2016-05-28
Date Mfgr Received2019-09-24
Date Added to Maude2019-10-02
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 LISA CLARK
Manufacturer Street5405 WINDWARD PARKWAY
Manufacturer CityALPHARETTA GA 30004
Manufacturer CountryUS
Manufacturer Postal30004
Manufacturer Phone4704485444
Manufacturer G1PRO-TECH
Manufacturer Street14561 MARQUARDT AVE
Manufacturer CitySANTA FE SPRINGS CA 90670
Manufacturer CountryUS
Manufacturer Postal Code90670
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameENDOCLEAR RESTORE
Generic NameTRACHEOBRONCHIAL SUCTION CATHETER
Product CodeBSY
Date Received2019-10-02
Model NumberEC-100-01
Lot Number9435572
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerAVANOS MEDICAL, INC.
Manufacturer Address5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2019-10-02

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