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 2003-07-28 for manufactured by .

MAUDE Entry Details

Report Number9614110-2003-00001
MDR Report Key476771
Report Source05
Date Received2003-07-28
Date Mfgr Received2003-07-07
Date Added to Maude2003-08-12
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 FDA0
Event Location0
Manufacturer StreetCROWN HOUSE HORNBEAM SQUARE NORTH
Manufacturer CityHARROGATE, NORTH YORKSHIRE HG2 8PB
Manufacturer CountryUK
Manufacturer PostalHG2 8PB
Manufacturer Phone702408036
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Remedial ActionRB
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Product CodeNEA
Date Received2003-07-28
Device Eval'ed by MfgrR
Implant FlagY
Device Sequence No1
Device Event Key465584


Patients

Patient NumberTreatmentOutcomeDate
10 2003-07-28

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