MAUDE Adverse Event Report: TSO3 INC. STERIZONE VP4 STERILIZER; TWO OR MORE STERILANT STERILIZER

Model Number	44000-R
Health Effect - Clinical Codes	Skin Irritation (2076); Caustic/Chemical Burns (2549)
Date of Event	06/21/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a user of the device experienced slight burn/chemical irritation on her hand.There was no report of a medical treatment associated with the alleged event.

• Brand Name: STERIZONE VP4 STERILIZER
• Common Device Name: TWO OR MORE STERILANT STERILIZER
• Manufacturer (Section D): TSO3 INC.; 2505 dalton avenue; quebec, quebec G1P 3 S5; CA G1P 3S5
• MDR Report Key: 6734047
• Report Number: 3011762828-2017-00003
• Device Sequence Number: 1371952
• Product Code: PJJ
• UDI-Device Identifier: 00690455440003
• UDI-Public: (01)00690455440003
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/21/2017
• Report Date (Section F): 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: 44000-R
• Device Catalogue Number: 44000-R
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/22/2017
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/21/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 07/21/2017