MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2001-06-05 for manufactured by .

MAUDE Entry Details

Report Number8044101-2001-00001
MDR Report Key336338
Report Source04
Date Received2001-06-05
Date of Event2001-05-09
Date Mfgr Received2001-05-09
Device Manufacturer Date2000-04-01
Date Added to Maude2001-06-11
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 ContactMARY LEEPER, PHD
Manufacturer Street875 N MICHIGAN AVE #3660
Manufacturer CityCHICAGO IL 60611
Manufacturer CountryUS
Manufacturer Postal60611
Manufacturer Phone3122809917
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Product CodeMBU
Date Received2001-06-05
Device Eval'ed by MfgrN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key325642


Patients

Patient NumberTreatmentOutcomeDate
10 2001-06-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.