InjuryPJJ
STERIZONE VP4 STERILIZER
Received Jul 21, 2017 · Event occurred Jun 21, 2017
Report 3004148947-2017-00003 · MDR key 6734048
Device
Product problems
- Improper or Incorrect Procedure or Method
- Improper or Incorrect Procedure or Method
Patient
Not reported
- Skin Irritation
- Caustic/Chemical Burns
- Skin Irritation
- Caustic/Chemical Burns
Narrative
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.
Description of Event or Problem
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.