ECLIPSE2L ECL2L6X15 N/A

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 2020-02-24 for ECLIPSE2L ECL2L6X15 N/A manufactured by Balt Usa, Llc.

MAUDE Entry Details

Report Number3014162263-2020-00003
MDR Report Key9747866
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-02-24
Date of Report2020-03-18
Date of Event2020-01-28
Date Mfgr Received2020-01-28
Device Manufacturer Date2019-12-13
Date Added to Maude2020-02-24
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 ContactMOISES COLIN
Manufacturer Street29 PARKER
Manufacturer CityIRVINE,
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameECLIPSE2L
Generic NameECLIPSE2L
Product CodeMJN
Date Received2020-02-24
Returned To Mfg2020-03-12
Model NumberECL2L6X15
Catalog NumberN/A
Lot NumberF191200103
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBALT USA, LLC
Manufacturer Address29 PARKER IRVINE, CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-02-24

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