MAUDE Adverse Event Report: STERIS CORPORATION PROLYSTICA; CLEANER

Model Number	1C3308
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via chemtrec report that an employee obtained burns on their knees while handling prolystica concentrate enzymatic cleaner.The employee sought medical treatment and received antibiotics.
Additional Manufacturer Narrative
Through follow-up with user facility personnel, it was discovered that when the employee subject of the reported event was lifting trays out of the processing sink when some of the cleaner made contact with her knees.The employee's apron was not covering her knees, subsequently causing the reported event.The prolystica sds states, "avoid all unnecessary exposure.Personal protective equipment should be selected based upon the conditions under which this product is handled or used.Protective clothing, gloves, protective goggles." steris provided in-service training on the proper use and operation of prolystica, specifically on wearing the proper ppe.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.
Additional Manufacturer Narrative
Contrary to the initial report, steris did not provide the in-service training but rather, the training was conducted by the user facility's health and safety department.

• Brand Name: PROLYSTICA
• 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 ; 4402597401
• MDR Report Key: 22976490
• Report Number: 1937531-2025-00007
• Device Sequence Number: 9391277
• Product Code: FLG
• UDI-Device Identifier: 00724995087517
• UDI-Public: (01)00724995087517
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2025

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
• 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: 08/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 10/27/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown