*

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 2005-03-07 for * manufactured by Ortho-clinical Diagnostics, Inc..

MAUDE Entry Details

Report Number2250051-2005-00081
MDR Report Key582410
Report Source05,06
Date Received2005-03-07
Date of Event2005-02-16
Date Mfgr Received2005-01-21
Date Added to Maude2005-03-18
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 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
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name*
Generic Name*
Product CodeLRH
Date Received2005-03-07
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device Availability*
Device Eval'ed by MfgrN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key572252
ManufacturerORTHO-CLINICAL DIAGNOSTICS, INC.
Manufacturer AddressROUTE 202 RARITAN NJ 08869 US


Patients

Patient NumberTreatmentOutcomeDate
10 2005-03-07

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