A1603, 6MM L/L STEALTH CLIP 3/4 F 10/BX NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-11-20 for A1603, 6MM L/L STEALTH CLIP 3/4 F 10/BX NA manufactured by Applied Medical Resources.

MAUDE Entry Details

Report Number2027111-2019-00642
MDR Report Key9351111
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-11-20
Date of Report2019-11-20
Date Mfgr Received2019-11-14
Date Added to Maude2019-11-20
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
Event Type3
Type of Report3

Device Details

Brand NameA1603, 6MM L/L STEALTH CLIP 3/4 F 10/BX
Generic NameCLIP, VASCULAR
Product CodeDSS
Date Received2019-11-20
Model NumberA1603
Catalog NumberNA
Lot NumberNA
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerAPPLIED MEDICAL RESOURCES
Manufacturer Address22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-20

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