STERIZONE VP4 STERILIZER 44000-R

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-07-21 for STERIZONE VP4 STERILIZER 44000-R manufactured by Tso3 Inc..

Event Text Entries

[80749808] Investigation on the device was conducted on site by service technician. All test verifications were performed and the unit met manufacturer specifications. There is no evidence that this event was related to a device defect or malfunction. The issue is associated with the use of the device in terms of non-conforming to the device's instructions and information provided by the device manufacturer.
Patient Sequence No: 1, Text Type: N, H10


[80749809] It was reported that a user of the device, upon reloading a cart while getting ready to load the machine, got a burning sensation coming from under the gloves, removed them and washed her hands. There was no report of a medical evaluation or medical treatment associated with the alleged event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004148947-2017-00002
MDR Report Key6734033
Report SourceDISTRIBUTOR
Date Received2017-07-21
Date of Report2017-07-21
Date of Event2017-06-21
Date Mfgr Received2017-06-22
Device Manufacturer Date2017-04-20
Date Added to Maude2017-07-21
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 ContactMR. ALEXANDRE JOKIC
Manufacturer Street2505 DALTON AVENUE
Manufacturer CityQUEBEC, QUEBEC G1P 3S5
Manufacturer CountryCA
Manufacturer PostalG1P 3S5
Manufacturer G1TSO3 INC.
Manufacturer Street2505 DALTON AVENUE
Manufacturer CityQUEBEC, QUEBEC G1P 3S5
Manufacturer CountryCA
Manufacturer Postal CodeG1P 3S5
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSTERIZONE VP4 STERILIZER
Generic NameTWO OR MORE STERILANT STERILIZER
Product CodePJJ
Date Received2017-07-21
Model Number44000-R
Catalog Number44000-R
Lot NumberNA
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTSO3 INC.
Manufacturer Address2505 DALTON AVENUE QUEBEC, QUEBEC G1P 3S5 CA G1P 3S5


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-07-21

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