EMEA CIDEX? OPA SOLUTION 20391

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-06-20 for EMEA CIDEX? OPA SOLUTION 20391 manufactured by Advanced Sterilization Products.

MAUDE Entry Details

Report Number2084725-2019-00888
MDR Report Key8719370
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-06-20
Date of Report2019-05-23
Date of Event2019-05-19
Date Mfgr Received2019-09-16
Device Manufacturer Date2018-06-21
Date Added to Maude2019-06-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. GABRIELA MCLELLAN
Manufacturer Street33 TECHNOLOGY DRIVE
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone949453-639
Manufacturer G1ADVANCED STERILIZATION PRODUCTS
Manufacturer Street33 TECHNOLOGY DRIVE
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal Code92618
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEMEA CIDEX? OPA SOLUTION
Generic NameBIOCIDES SOLUTIONS
Product CodeMED
Date Received2019-06-20
Returned To Mfg2019-06-29
Catalog Number20391
Lot Number250618170
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerADVANCED STERILIZATION PRODUCTS
Manufacturer Address33 TECHNOLOGY DRIVE IRVINE CA 92618 US 92618


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2019-06-20

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