inforMED
MalfunctionMLR

VAPROX

Received Feb 24, 2026 · Event occurred Feb 5, 2026

Report 3003950207-2026-00003 · MDR key 24435956

Device

Generic name

Vaprox Sterilant

Manufacturer

Steris Corporation

Lot number

(10)HC2975P1

Product problems

  • Leak/Splash

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 TO THEIR HANDS WHILE HANDLING A LEAKING CARTON OF VAPROX HC STERILANT. THE EMPLOYEE WASHED THEIR HANDS AND CONTINUED WORKING.