MAUDE Adverse Event Report: STERIS Corporation Prolystica; Enzymatic Manual Cleaner

Model Number	1C2310
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	08/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that employees experienced hives after handling prolystica enzymatic manual cleaner.It is unknown if medical treatment was sought or administered.
Additional Manufacturer Narrative
Investigation of the event is currently in progress.A follow-up report will be submitted when additional information becomes available.Udi related data clarification ¿ the lot/serial number is unknown; therefore, the applicable production identifiers were not included in the mdr.

• Brand Name: Prolystica
• Common Device Name: Enzymatic Manual Cleaner
• Manufacturer (Section D): STERIS Corporation; 7501 page ave; saint louis MO 63133
• Manufacturer (Section G): STERIS Corporation; 7501 page ave; saint louis MO 63133
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor 44060 ; +1(440)259-7401
• MDR Report Key: 50818129
• Report Number: 1937531-2026-00007
• Device Sequence Number: 13301408
• Product Code: FLG
• UDI-Device Identifier: 00724995224943
• UDI-Public: (01)00724995224943
• 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): 09/18/2026

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: 1C2310
• Device Catalogue Number: 1C2310
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 09/18/2026
• 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