*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2004-01-07 for * manufactured by *.

MAUDE Entry Details

Report Number1713747-2004-00175
MDR Report Key534688
Report Source05,06
Date Received2004-01-07
Date of Report2004-01-05
Date of Event2003-12-15
Date Mfgr Received2003-12-31
Date Added to Maude2004-07-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactELIZABETH POLHEMUS
Manufacturer Street95 HAYDEN AVE TWO LEDGEMONT CENTER
Manufacturer CityLEXINGTON MA 02173
Manufacturer CountryUS
Manufacturer Postal02173
Manufacturer Phone7814029075
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 CodeLIF
Date Received2004-01-07
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device Availability*
Device Eval'ed by MfgrR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key523953
Manufacturer*
Manufacturer Address* * US


Patients

Patient NumberTreatmentOutcomeDate
10 2004-01-07

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