inforMED
MalfunctionMLR

VAPROX

Received Apr 3, 2026 · Event occurred Mar 18, 2026

Report 3003950207-2026-00010 · MDR key 24778623

Device

Generic name

Vaprox Sterilant

Manufacturer

Steris Corporation

Lot number

(10)HC2555P1

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.