DURAVENT VT TB 1.27MM TP (60/PK) 245775

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-13 for DURAVENT VT TB 1.27MM TP (60/PK) 245775 manufactured by Gyrus Acmi, Inc.

MAUDE Entry Details

Report Number2951238-2020-00378
MDR Report Key9832558
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-03-13
Date of Report2020-03-13
Date of Event2020-02-28
Date Mfgr Received2020-02-28
Date Added to Maude2020-03-13
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. CONNIE TUBERA
Manufacturer Street2400 RINGWOOD AVENUE
Manufacturer CitySAN JOSE CA 95131
Manufacturer CountryUS
Manufacturer Postal95131
Manufacturer Phone4089355124
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDURAVENT VT TB 1.27MM TP (60/PK)
Generic NameDURAVENT VT TB
Product CodeETD
Date Received2020-03-13
Model Number245775
Lot NumberLZ847720
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerGYRUS ACMI, INC
Manufacturer Address136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US 01772


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-13

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