MAUDE Adverse Event Report: STERIS CORPORATION PROLYSTICA; CLEANER

Model Number	1C3308
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Rash (2033)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that two employees obtained a burn and a rash on their stomach and forearms after contacting prolystica 2x concentrate enzymatic presoak and cleaner.It is unknown if medical treatment was sought or administered.
Additional Manufacturer Narrative
A steris sales representative was informed that the employees were not wearing proper ppe at the time of the reported event, specifically gloves, protective clothing, and eye and face protection.The employees subject of the reported event received a copy of the safety data sheet (sds).The safety data sheets states to wear protective gloves, protective clothing, eye and face protection.In case of inadequate ventilation, wear respiratory protection.If on skin, wash with plenty of soap and water.If irritation occurs, get medical attention.The safety data sheet further states, first aid measures after skin contact - "immediately flush skin with plenty of water for at least 15 minutes.Remove immediately all contaminated clothing.Rinse skin with water.Get medical advice/attention." user facility personnel were counseled on the importance of wearing proper ppe, specifically wearing proper gloves, protective clothing, eye and face protection.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: 21170626
• Report Number: 1937531-2025-00003
• Device Sequence Number: 4276017
• Product Code: FLG
• UDI-Device Identifier: 00724995087517
• UDI-Public: (01)00724995087517
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 01/16/2025

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: 12/19/2024
• Initial Report FDA Received Date: 01/16/2025
• 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