MAUDE Adverse Event Report: STERIS CORPORATION PROLYSTICA 2X CONCENTRATE ENZYMATIC PRESOAK AND CLEANER

Model Number	1C3308
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported an employee experienced a "facial reaction" while handling prolystica 2x concentrate enzymatic presoak and cleaner.Medical treatment was sought and administered (allergy medication).
Additional Manufacturer Narrative
A steris account manager arrived onsite following the reported event and learned the room in which the employee was handling the prolystica lacked proper ventilation.While onsite, the steris account manager opened the room's air vents to help restore proper ventilation.The prolystica 2x concentrate enzymatic presoak and cleaner safety data sheet states, "section 7: handling and storage, provide good ventilation in process area to prevent formation of vapor." steris account manager counseled user facility personnel on the proper use and operation with the prolystica 2x concentrate enzymatic presoak and cleaner, specifically, in ensuring proper ventilation where the product is being used.The device history record was reviewed for the subject lot and confirmed the lot was manufactured to specifications; no abnormalities were noted.There have been no other complaints associated with this lot.No additional issues have been reported.

• Brand Name: PROLYSTICA 2X CONCENTRATE ENZYMATIC PRESOAK AND CLEANER
• Common Device Name: CLEANER
• Manufacturer (Section D): STERIS CORPORATION; 7501 page avenue; st. louis MO 63133
• Manufacturer (Section G): STERIS CORPORATION; 7501 page avenue; st. louis MO 63133
• Manufacturer Contact: daniel davy ; 5960 heisley rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 21943036
• Report Number: 1937531-2025-00006
• Device Sequence Number: 8554287
• Product Code: FLG
• UDI-Device Identifier: 00724995087517
• UDI-Public: (01)00724995087517(17)270101(10)333976
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1C3308
• Device Catalogue Number: 1C3308
• Device Lot Number: (10)333976
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown