XEN 45 GTS 5513-001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for XEN 45 GTS 5513-001 manufactured by Allergan (irvine).

MAUDE Entry Details

Report Number3011299751-2020-00119
MDR Report Key9908241
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-02
Date Mfgr Received2020-03-02
Device Manufacturer Date2020-01-07
Date Added to Maude2020-03-31
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 ContactMRS. MICHELLE BURGESS
Manufacturer Street12331-A RIATA TRACE PARKWAY BUILDING 3
Manufacturer CityAUSTIN TX 78727
Manufacturer CountryUS
Manufacturer Postal78727
Manufacturer Phone7372473605
Manufacturer G1ALLERGAN (IRVINE)
Manufacturer Street2525 DUPONT DRIVE
Manufacturer CityIRVINE CA 92612
Manufacturer CountryUS
Manufacturer Postal Code92612
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameXEN 45 GTS
Generic NameIMPLANT, EYE VALVE
Product CodeKYF
Date Received2020-03-31
Catalog Number5513-001
Lot Number63089
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerALLERGAN (IRVINE)
Manufacturer Address2525 DUPONT DRIVE IRVINE CA 92612 US 92612


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-31

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