MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2005-11-29 for manufactured by .

MAUDE Entry Details

Report Number2250051-2005-00561
MDR Report Key650088
Report Source05,06
Date Received2005-11-29
Date of Event2005-10-31
Date Mfgr Received2005-10-31
Device Manufacturer Date2005-06-01
Date Added to Maude2005-12-08
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 ContactLAURA VELLUCCI, PH.D
Manufacturer Street1001 US HWY 202
Manufacturer CityRARITAN NJ 08869
Manufacturer CountryUS
Manufacturer Postal08869
Manufacturer Phone9082188532
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Product CodeJCM
Date Received2005-11-29
Device Eval'ed by Mfgr*
Implant FlagN
Device Sequence No1
Device Event Key639561
Baseline Brand NameSICKLEDEX
Baseline Generic NameNA
Baseline Model NoNA
Baseline Catalog No773500
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
10 2005-11-29

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