inforMED
MalfunctionMLR

VAPROX HC STERILANT

Received Mar 28, 2024 · Event occurred Mar 1, 2024

Report 3003950207-2024-00003 · MDR key 18990133

Device

Generic name

Sterilant

Model number

PB007

Catalog number

PB007

Product problems

  • Insufficient Device Problem Information
  • Insufficient Device Problem Information

Patient

NA · Unknown

  • Burn(s)
  • Burn(s)

Narrative

Additional Manufacturer Narrative

A STERIS ACCOUNT MANAGER MADE MULTIPLE ATTEMPTS TO CONTACT USER FACILITY PERSONNEL TO OBTAIN INFORMATION REGARDING THE REPORTED EVENT HOWEVER, THE USER FACILITY HAS NOT RESPONDED. NO ADDITIONAL ISSUES REGARDING THE VAPROX CARTRIDGES HAVE BEEN REPORTED.

Additional Manufacturer Narrative

INVESTIGATION OF THIS EVENT IS CURRENTLY IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE USER FACILITY REPORTED THAT AN EMPLOYEE EXPERIENCED A "BURN" TO THEIR HANDS FROM HANDLING VAPROX CARTRIDGES. IT IS UNKNOWN IF THE EMPLOYEE SOUGHT OR RECEIVED MEDICAL TREATMENT.