MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,08 report with the FDA on 2008-05-30 for manufactured by .

MAUDE Entry Details

Report Number8010042-2008-00068
MDR Report Key1103623
Report Source01,05,06,08
Date Received2008-05-30
Date Mfgr Received2008-05-22
Date Added to Maude2008-08-12
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 FDA3
Event Location0
Manufacturer ContactJAMIE YIEH
Manufacturer Street1140 ROUTE 22 E, STE 202
Manufacturer CityBRIDGEWATER NJ 08807
Manufacturer CountryUS
Manufacturer Postal08807
Manufacturer Phone9089472311
Manufacturer G1MAQUET CRITICAL CARE AB
Manufacturer Street*
Manufacturer City* S-171 54
Manufacturer CountrySW
Manufacturer Postal CodeS-171 54
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Product CodeMOD
Date Received2008-05-30
Device Eval'ed by MfgrN
Implant FlagN
Device Sequence No1
Device Event Key1082877


Patients

Patient NumberTreatmentOutcomeDate
10 2008-05-30

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