MAUDE Adverse Event Report: STERIS CORPORATION PROLYSTICA; PRESOAK AND CLEANER

Model Number	1C3308
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Skin Burning Sensation (4540)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
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.

• Brand Name: PROLYSTICA
• Common Device Name: PRESOAK AND 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 ; 4402597401
• MDR Report Key: 24649704
• Report Number: 1937531-2026-00002
• Device Sequence Number: 21372372
• Product Code: FLG
• UDI-Device Identifier: 00724995087517
• UDI-Public: (01)00724995087517
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 03/20/2026

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown