MalfunctionMLR
VAPROX
Received Apr 3, 2026 · Event occurred Mar 18, 2026
Report 3003950207-2026-00010 · MDR key 24778623
Device
Product problems
- Device Damaged Prior to Receipt by User
Patient
NA · Unknown
- Burn(s)
Narrative
Additional Manufacturer Narrative
INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE. IT SHOULD BE NOTED THAT THIS SPECIFIC MODEL IS NOT SOLD IN THE UNITED STATES, SO IT IS NOT IN GUDID.
Description of Event or Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A BURN ON THEIR HANDS WHILE HANDLING A PACKAGE OF VAPROX HC STERILANT THAT WAS DAMAGED UPON ARRIVAL. NO MEDICAL TREATMENT WAS ADMINISTERED AND THE EMPLOYEE RETURNED TO WORK.