*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-05-20 for * manufactured by *.

MAUDE Entry Details

Report Number1018233-2004-00027
MDR Report Key528892
Report Source05
Date Received2004-05-20
Date of Event2004-01-24
Date Mfgr Received2004-04-27
Date Added to Maude2004-06-10
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 Location0
Manufacturer ContactVIVIAN STEPHENS, MGR
Manufacturer Street8195 INDUSTRIAL BLVD
Manufacturer CityCOVINGTON GA 30014
Manufacturer CountryUS
Manufacturer Postal30014
Manufacturer Phone7707846902
Manufacturer G1BARD MEDICAL
Manufacturer StreetKM 7 CARRETERA INTERNACIONAL
Manufacturer CityNOGALES, SONORA 84000
Manufacturer CountryMX
Manufacturer Postal Code84000
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name*
Generic Name*
Product CodeEBR
Date Received2004-05-20
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device Availability*
Device Eval'ed by MfgrR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key518080
Manufacturer*
Manufacturer Address* * US


Patients

Patient NumberTreatmentOutcomeDate
10 2004-05-20

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