*

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 2002-11-05 for * manufactured by *.

MAUDE Entry Details

Report Number2250051-2002-00165
MDR Report Key426865
Report Source05
Date Received2002-11-05
Date of Event2002-07-17
Date Mfgr Received2002-07-26
Date Added to Maude2002-11-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactJUDY STRZEPEK
Manufacturer Street1001 US HWY 202
Manufacturer CityRARITAN NJ 088690606
Manufacturer CountryUS
Manufacturer Postal088690606
Manufacturer Phone9087048524
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

Brand Name*
Generic Name*
Product CodeLRH
Date Received2002-11-05
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device Availability*
Device Eval'ed by MfgrN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key415884
Manufacturer*
Manufacturer Address* * *


Patients

Patient NumberTreatmentOutcomeDate
10 2002-11-05

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