BRYAN DUMON SILICONE STENT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-28 for BRYAN DUMON SILICONE STENT manufactured by Lymol Medical Corporation.

MAUDE Entry Details

Report Number9244400
MDR Report Key9244400
Date Received2019-10-28
Date of Report2019-09-09
Date of Event2019-09-05
Report Date2019-09-09
Date Reported to FDA2019-09-09
Date Reported to Mfgr2019-10-28
Date Added to Maude2019-10-28
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameBRYAN DUMON SILICONE STENT
Generic NameBRONCHOSCOPE (FLEXIBLE OR RIGID)
Product CodeNWA
Date Received2019-10-28
Lot Number3831591
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerLYMOL MEDICAL CORPORATION
Manufacturer Address4 PLYMPTON ST WOBURN MA 01801 US 01801


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-28

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