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 2003-03-21 for manufactured by .

MAUDE Entry Details

Report Number2250051-2003-00068
MDR Report Key450313
Report Source05
Date Received2003-03-21
Date of Event2002-04-01
Date Mfgr Received2002-04-01
Date Added to Maude2003-03-28
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 ContactNANCY PAPCIAK
Manufacturer Street1001 US HWY 202
Manufacturer CityRARITAN NJ 088690606
Manufacturer CountryUS
Manufacturer Postal088690606
Manufacturer Phone9087043872
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 CodeJTL
Date Received2003-03-21
Device Eval'ed by MfgrN
Implant FlagN
Device Sequence No1
Device Event Key439308
Baseline Brand NameORTHO SUMMIT PROCESSOR
Baseline Generic NameSAMPLE PROCESSOR
Baseline Model No7003015
Baseline Catalog No936480
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
10 2003-03-21

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