STRATUSOCT 3000 NA

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 2005-03-18 for STRATUSOCT 3000 NA manufactured by Carl Zeiss Meditec Inc.

Event Text Entries

[410620] A patient experienced an electrostatic discharge whle taking an exam. The discharge occurred in the vicinity of the patient's eye.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2918630-2005-00002
MDR Report Key585450
Report Source05
Date Received2005-03-18
Date of Report2005-03-18
Date of Event2005-03-02
Date Mfgr Received2005-03-02
Device Manufacturer Date2004-03-01
Date Added to Maude2005-03-29
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 Street5160 HACIENDA DRIVE
Manufacturer CityDUBLIN CA 94568
Manufacturer CountryUS
Manufacturer Postal94568
Manufacturer Phone9255574353
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Remedial ActionMA
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameSTRATUSOCT
Generic NameOPTICAL CORNEAL TOMOGRAPHY
Product CodeHLI
Date Received2005-03-18
Model Number3000
Catalog NumberNA
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key575282
ManufacturerCARL ZEISS MEDITEC INC
Manufacturer Address* DUBLIN CA * US
Baseline Brand NameSTRATUS OCT
Baseline Generic NameOPTICAL CORNEAL TOMOGRAPHY
Baseline Model No3000
Baseline Catalog No00203-01
Baseline Device FamilyOCT
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK030433
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2005-03-18

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