BIVONA 0P055

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-08-22 for BIVONA 0P055 manufactured by Smiths Medical Asd, Inc.

MAUDE Entry Details

Report Number3012307300-2019-04222
MDR Report Key8923203
Report SourceUSER FACILITY
Date Received2019-08-22
Date of Report2019-08-22
Date Mfgr Received2018-12-03
Device Manufacturer Date2017-09-29
Date Added to Maude2019-08-22
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 ContactDAVE HALVERSON
Manufacturer Street6000 NATHAN LANE NORTH
Manufacturer CityMINNEAPOLIS MN 55442
Manufacturer CountryUS
Manufacturer Postal55442
Manufacturer G1SMITHS MEDICAL ASD, INC.
Manufacturer Street5700 WEST 23RD AVENUE
Manufacturer CityGARY IN 46406
Manufacturer CountryUS
Manufacturer Postal Code46406
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBIVONA
Generic NameTUBE, TRACHEOSTOMY (W/WO CONNECTOR)
Product CodeBTO
Date Received2019-08-22
Returned To Mfg2018-02-10
Catalog Number0P055
Lot Number3502385
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD, INC
Manufacturer Address6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-22

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