MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,08 report with the FDA on 2002-04-19 for manufactured by .

MAUDE Entry Details

Report Number9614110-2002-00001
MDR Report Key390977
Report Source00,05,08
Date Received2002-04-19
Date of Event2002-03-19
Date Mfgr Received2002-04-11
Device Manufacturer Date2001-02-01
Date Added to Maude2002-05-02
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 StreetSTRELLEY HALL STRELLEY VILLAGE
Manufacturer CityNOTTINGHAM, NOTTINGHAMSHIRE NG8 6PE
Manufacturer CountryUK
Manufacturer PostalNG8 6PE
Manufacturer Phone9061290
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Product CodeNEA
Date Received2002-04-19
Device Eval'ed by MfgrR
Implant FlagY
Device Sequence No1
Device Event Key380023


Patients

Patient NumberTreatmentOutcomeDate
10 2002-04-19

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