inforMED
MalfunctionMLR

VAPROX

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

Report 3003950207-2026-00007 · MDR key 24631101

Device

Generic name

Vaprox Sterilant

Manufacturer

Steris Corporation

Lot number

(10)HC2725P2

Product problems

  • Leak/Splash

Patient

NA · Unknown

  • Burn(s)

Narrative

Description of Event or Problem

THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A BURN AFTER CONTACTING A BOTTLE OF VAPROX HC STERILANT THAT HAD LEAKED IN THE PACKAGING. IT IS UNKNOWN IF THE EMPLOYEES SOUGHT OR RECEIVED MEDICAL TREATMENT.

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.