MAUDE Adverse Event Report: STERIS CORPORATION PROLYSTICA 2X CONCENTRATE ENZYMATIC PRESOAK AND CLEANER

Model Number	1C3308
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Eye Pain (4467)
Date of Event	02/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The report did not identify the name or location of the user facility of the product in question, therefore, additional information could not be obtained.To date, we have not been informed of this event directly from the user facility.The prolystica 2x concentrate enzymatic presoak and cleaner sds provides the following language and guidance related to eye exposure: "in case of contact with eyes flush immediately with plenty of flowing water for 10 to 15 minutes holding eyelids apart and consult an ophthalmologist.Remove contact lenses, if present and easy to do.Continue rinsing.Immediately get medical attention." the sds also provides the following language and guidance related to ppe: "wear chemical splash goggles.Wear rubber gloves or latex-free gloves." should additional information become available a follow-up report will be submitted.
Event or Problem Description
The user facility reported via chemtrec report that an individual experienced a left eye exposure to prolystica 2x concentrate enzymatic presoak and cleaner.Medical treatment was sought and administered (eye flush).

• Brand Name: PROLYSTICA 2X CONCENTRATE ENZYMATIC PRESOAK AND CLEANER
• 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: 16504687
• Report Number: 1937531-2023-00001
• Device Sequence Number: 6297324
• Product Code: FLG
• UDI-Device Identifier: 00724995087517
• UDI-Public: 00724995087517
• Combination Product (Y/N): N
• 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): 03/08/2023

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2023
• Initial Report FDA Received Date: 03/08/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown