MAUDE Adverse Event Report: STERIS CORPORATION PROLYSTICA; CLEANER

Model Number	1C2408
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	12/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that an employee experienced "nose, cheek and eye swelling and blistering" while handling prolystica hp enzymatic manual cleaner.The employee received an antibiotic and topical ointment.
Additional Manufacturer Narrative
It was confirmed that proper ppe, specifically eye protection was not worn at the time of the event.The employee subject of the reported event dropped their hose into the sink while washing instruments causing the prolystica hp enzymatic manual cleaner to splash underneath their faceshield.The prolystica hp enzymatic manual cleaner safety data sheet (sds) states, "personal protective equipment should be selected based upon the conditions under which this product is handled and used.Protective clothing, gloves, protective goggles.Wear rubber gloves or latex-free gloves, wear chemical splash goggles or safety glasses, wear suitable protective clothing." user facility personnel were counseled on the importance of wearing proper eye protection when handling prolystica.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.

• 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 ; 4403927453
• MDR Report Key: 21072215
• Report Number: 1937531-2025-00001
• Device Sequence Number: 8398861
• Product Code: FLG
• UDI-Device Identifier: 00724995211561
• UDI-Public: (01)00724995211561
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/03/2025

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: 1C2408
• Device Catalogue Number: 1C2408
• 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: 12/06/2024
• Initial Report FDA Received Date: 01/03/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown