MAUDE Adverse Event Report: STERIS CORPORATION PROLYSTICA; CLEANER

Model Number	1C3308
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Eye Irritation (4803)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
User facility personnel reported via a chemtrec report that when an employee was cleaning instruments, prolystica 2x concentrate enzymatic presoak and cleaner "splashed" into their eyes.The employee immediately rinsed their eyes with water and reported "burning and irritation.".
Additional Manufacturer Narrative
Following the reported event, user facility personnel stated they contacted chemtrec for further guidance regarding the exposure to the prolystica 2x concentrate enzmatic presoak and cleaner.The safety data sheet states: "first-aid measures after eye contact: in case of contact with eyes, flush immediately with plenty of flowing water for 10-15 minutes holding eyelids apart and consult an opthalmologist.Remove contact lenses if present and easy to do.Continue rinsing.Immediately get medical attention." "personal protective equipment: avoid all unnecessary exposure.Personal protective equipment should be selected based upon the conditions under which the product is handled or used.Protective clothing, gloves, protective goggles." steris has not received additional information regarding the reported event.A follow-up report will be submitted should additional information become 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: 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: 21126895
• Report Number: 1937531-2025-00002
• Device Sequence Number: 20752358
• Product Code: FLG
• UDI-Device Identifier: 00724995087517
• UDI-Public: (01)00724995087517
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 01/10/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 01/10/2025
• 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