Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TSO3 INC. STERIZONE VP4 STERILIZER; TWO OR MORE STERILANT STERILIZER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TSO3 INC. STERIZONE VP4 STERILIZER; TWO OR MORE STERILANT STERILIZER Back to Search Results
Model Number 44000-R
Medical Device Problem Code Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes Skin Irritation (2076); Caustic/Chemical Burns (2549)
Date of Event 06/21/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
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.
 
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key6734048
Report Number3004148947-2017-00003
Device Sequence Number881720
Product Code PJJ
UDI-Device Identifier00690455440003
UDI-Public(01)00690455440003
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K153689
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 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 Number44000-R
Device Catalogue Number44000-R
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/22/2017
Initial Report FDA Received Date07/21/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
-
-