*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-01-21 for * manufactured by .

MAUDE Entry Details

Report Number1626179-1997-00002
MDR Report Key64924
Date Received1997-01-21
Date Mfgr Received1997-01-08
Device Manufacturer Date1996-08-01
Date Added to Maude1997-01-29
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
Remedial ActionIN
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name*
Product CodeKTB
Date Received1997-01-21
Device Eval'ed by MfgrR
Implant FlagN
Device Sequence No1
Device Event Key57399


Patients

Patient NumberTreatmentOutcomeDate
10 1997-01-21

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