OXYSEPT OXYTC

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,health profe report with the FDA on 2019-10-28 for OXYSEPT OXYTC manufactured by Johnson & Johnson Surgical Vision, Inc..

MAUDE Entry Details

Report Number3004178847-2019-00012
MDR Report Key9243475
Report SourceCONSUMER,FOREIGN,HEALTH PROFE
Date Received2019-10-28
Date of Report2019-10-27
Date of Event2019-09-26
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2019-09-26
Device Manufacturer Date2018-11-06
Date Added to Maude2019-10-28
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 ContactSOMYATA NAGPAL
Manufacturer Street1700 EAST ST. ANDREW PLACE
Manufacturer CitySANTA ANA CA 92705
Manufacturer CountryUS
Manufacturer Postal92705
Manufacturer Phone7142478200
Manufacturer G1JOHNSON & JOHNSON SURGICAL VISION, INC.
Manufacturer Street4TH AVE HZ ECON/TECH DEVELOP. ZONE
Manufacturer CityHANGZHOU 310018
Manufacturer CountryCN
Manufacturer Postal Code310018
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameOXYSEPT
Generic NameACCESSORIES
Product CodeLPN
Date Received2019-10-28
Model NumberOXYTC
Lot NumberZE04472
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerJOHNSON & JOHNSON SURGICAL VISION, INC.
Manufacturer Address1700 E ST ANDREW PLACE SANTA ANA CA 92705 US 92705


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-28

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