CNB11, GELPOINT PATH WITH ISB, 5.5CM UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-09-18 for CNB11, GELPOINT PATH WITH ISB, 5.5CM UNKNOWN manufactured by Applied Medical Resources.

MAUDE Entry Details

Report Number2027111-2019-00592
MDR Report Key9084499
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-09-18
Date of Report2019-09-18
Date of Event2019-06-21
Date Mfgr Received2019-09-09
Date Added to Maude2019-09-18
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 ContactWENDY KOBAYASHI
Manufacturer Street22872 AVENIDA EMPRESA
Manufacturer CityRANCHO SANTA MARGARITA CA 92688
Manufacturer CountryUS
Manufacturer Postal92688
Manufacturer Phone9497138059
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameCNB11, GELPOINT PATH WITH ISB, 5.5CM
Generic NameANOSCOPE AND ACCESSORIES
Product CodeFER
Date Received2019-09-18
Returned To Mfg2019-08-22
Model NumberCNB11
Catalog NumberUNKNOWN
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerAPPLIED MEDICAL RESOURCES
Manufacturer Address22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-18

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