MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 1998-06-12 for manufactured by .

MAUDE Entry Details

Report Number1314329-1998-00001
MDR Report Key172245
Report Source06,07
Date Received1998-06-12
Date of Event1998-04-28
Date Mfgr Received1998-05-14
Device Manufacturer Date1991-10-01
Date Added to Maude1998-06-16
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 CodeFLH
Date Received1998-06-12
Device Eval'ed by MfgrY
Implant FlagN
Device Sequence No1
Device Event Key167494
Baseline Brand NameCASTLE M/C6927 WASHER/STERILIZER
Baseline Generic NameWASHER/STERILIZER
Baseline Model NoM/C927
Baseline Catalog NoNA
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
10 1998-06-12

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