MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-10-23 for manufactured by .

MAUDE Entry Details

Report Number1043615-1997-90001
MDR Report Key128269
Date Received1997-10-23
Date of Event1997-09-10
Date Added to Maude1997-10-28
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Product CodeBRT
Date Received1997-10-23
Device Eval'ed by Mfgr*
Implant FlagN
Device Sequence No1
Device Event Key125500


Patients

Patient NumberTreatmentOutcomeDate
10 1997-10-23

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