MalfunctionMLR
VAPROX
Received Dec 31, 2024 · Event occurred Dec 17, 2024
Report 3003950207-2024-00011 · MDR key 21049288
Device
Generic name
Vaprox Hc Sterilant
Manufacturer
Steris CorporationModel number
PB007Catalog number
PB007
Lot number
(10)HC2154P1
Product problems
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
Patient
NA · Unknown
- Headache
- Headache
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE EXPERIENCED INHALATION/IRRITATION EFFECTS (HEADACHE AND DIFFICULTY BREATHING) WHILE HANDLING VAPROX HC STERILANT. THE USER FACILITY DID NOT DISCLOSE IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.
Additional Manufacturer Narrative
INVESTIGATION OF THIS EVENT IS CURRENTLY IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN 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.