PROLYSTICA
Received Mar 20, 2026 · Event occurred Feb 18, 2026
Report 1937531-2026-00002 · MDR key 24649704
Device
Product problems
- Insufficient Device Problem Information
Patient
NA · Unknown
- Skin Burning Sensation
Narrative
Additional Manufacturer Narrative
STERIS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT HOWEVER, THE USER FACILITY HAS NOT RESPONDED. THE LOT NUMBER FOR THE PROLYSTICA 2X CONCENTRATE ENZYMATIC PRESOAK AND CLEANER SUBJECT OF THE REPORTED EVENT WAS NOT PROVIDED. AS THE LOT NUMBER IS UNKNOWN, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THE PROLYSTICA 2X CONCENTRATE ENZYMATIC PRESOAK AND CLEANER LABEL STATES, "CAUSES SKIN IRRITATION. WEAR PROTECTIVE GLOVES, PROTECTIVE CLOTHING, EYE AND FACE PROTECTION. IF ON SKIN, WASH WITH PLENTY OF SOAP AND WATER. IF SKIN IRRITATION OCCURS, GET MEDICAL ATTENTION." NO ADDITIONAL ISSUES HAVE BEEN REPORTED. UDI RELATED DATA CLARIFICATION - THE LOT/SERIAL NUMBER IS UNKNOWN; THEREFORE, THE APPLICABLE PRODUCTION IDENTIFIERS WERE NOT INCLUDED IN THE MDR.
Description of Event or Problem
THE USER FACILITY REPORTED THAT EMPLOYEES ARE EXPERIENCING "SKIN IRRITATION" WHILE HANDLING PROLYSTICA 2X CONCENTRATE ENZYMATIC PRESOAK AND CLEANER. IT IS UNKNOWN IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.