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

Model Number 1C3308

Device Problem Insufficient Information (3190)

Patient Problem Eye Pain (4467)

Event Date 02/09/2023

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 310999245
• Report Number: 1937531-2023-00001
• Device Sequence Number: 1
• Product Code: FLG
• UDI-Device Identifier: 00724995087517
• UDI-Public: 00724995087517
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1C3308
• Device Catalogue Number: 1C3308
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1