VENTLAB S-2101F

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-04 for VENTLAB S-2101F manufactured by Sunmed Holdings Llc..

MAUDE Entry Details

Report Number1314417-2019-00053
MDR Report Key9155523
Date Received2019-10-04
Date of Report2019-10-03
Date of Event2019-08-28
Date Added to Maude2019-10-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. CARRIE FORTUNA
Manufacturer Street2710 NORTHRIDGE DR. NW. SUITE A
Manufacturer CityGRAND RAPIDS MI 49544
Manufacturer CountryUS
Manufacturer Postal49544
Manufacturer Phone6162598400
Manufacturer G1SUNMED HOLDINGS LLC.
Manufacturer Street2710 NORTHRIDGE DR. NW SUITE A
Manufacturer CityGRAND RAPIDS MI 49544
Manufacturer CountryUS
Manufacturer Postal Code49544
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameVENTLAB
Generic NameOXYGEN MASK
Product CodeBYG
Date Received2019-10-04
Model NumberS-2101F
Lot Number240214
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSUNMED HOLDINGS LLC.
Manufacturer Address2710 NORTHRIDGE DR. NW SUITE A GRAND RAPIDS MI 49544 US 49544


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-04

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