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 2000-05-24 for manufactured by .

MAUDE Entry Details

Report Number2250051-2000-00058
MDR Report Key279676
Report Source05
Date Received2000-05-24
Date of Event2000-03-29
Date Mfgr Received2000-04-12
Date Added to Maude2000-06-01
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag0
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA0
Event Location0
Manufacturer ContactCINDY ADEN
Manufacturer Street1001 US HWY 202
Manufacturer CityRARITAN NJ 08869
Manufacturer CountryUS
Manufacturer Postal08869
Manufacturer Phone9082188761
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Remedial ActionOT
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Product CodeLRH
Date Received2000-05-24
Device Eval'ed by MfgrN
Implant FlagN
Device Sequence No1
Device Event Key270654
Baseline Brand NameORTHO ELISA BAR CODE READER II
Baseline Generic NameBAR CODE READER
Baseline Model No9720C01,D01,E01
Baseline Catalog No935240
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
10 2000-05-24

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