DABRA DABRA 101 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-10-25 for DABRA DABRA 101 NA manufactured by Ra Medical Systems, Inc..

MAUDE Entry Details

Report Number2032864-2019-00008
MDR Report Key9239853
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-10-25
Date of Report2019-10-25
Date of Event2019-06-24
Date Mfgr Received2019-06-28
Device Manufacturer Date2019-06-17
Date Added to Maude2019-10-25
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 ContactVICKI CHESTER
Manufacturer Street2070 LAS PALMAS DR.
Manufacturer CityCARLSBAD CA 92011
Manufacturer CountryUS
Manufacturer Postal92011
Manufacturer Phone8776351800
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDABRA
Generic NameEXCIMER LASER CATHETER
Product CodePDU
Date Received2019-10-25
Model NumberDABRA 101
Catalog NumberNA
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerRA MEDICAL SYSTEMS, INC.
Manufacturer Address2070 LAS PALMAS DR. CARLSBAD CA 92011 US 92011


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-10-25

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