MAUDE Adverse Event Report: STERIS CORPORATION PROLYSTICA; PROLYSTICA HP ENZYMATIC MANUAL CLEANER DYE & FRAGRANCE

Model Number	1C2308
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Rash (2033)
Date of Event	10/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility did not provide the lot number for the prolystica hp enzymatic manual cleaner dye & fragrance subject of the reported event.As the lot number was not provided a review of the device history record (dhr) can not be performed.The products safety data sheet (sds) and label both state that gloves should be worn while handling the prolystica hp enzymatic manual cleaner dye & fragrance.The sds states, "personal protective equipment should be selected based upon the conditions under which this product is handled or used.Protective clothing.Gloves.Protective goggles.Wear rubber gloves or latex-free gloves." the prolystica hp enzymatic manual cleaner dye & fragrance label states, "wear eye protection, protective clothing, protective gloves." the user facility was provided a copy of the sds and counseled on the importance of wearing personal protective equipment (ppe) while handling prolystica hp enzymatic manual cleaner dye & fragrance.No additional issues have been reported.
Event or Problem Description
The user facility reported an employee obtained a rash on their hands and stomach after handling prolystica hp enzymatic manual cleaner dye & fragrance.The employee sought and received medical treatment.
Additional Manufacturer Narrative
Udi related data clarification - the lot/serial number is unknown, therefore, the applicable production identifiers were not included in the mdr.Udi related data quality updates only - alignment with gudid.

• Brand Name: PROLYSTICA
• Common Device Name: PROLYSTICA HP ENZYMATIC MANUAL CLEANER DYE & FRAGRANCE
• 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: 18151576
• Report Number: 1937531-2023-00004
• Device Sequence Number: 6721595
• Product Code: FLG
• UDI-Device Identifier: 00724995154363
• UDI-Public: (01)00724995154363
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2023

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: 1C2308
• Device Catalogue Number: 1C2308
• 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: 10/30/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 01/22/2025
• 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