MAUDE Adverse Event Report: STERIS CORPORATION PROLYSTICA; CLEANER

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	10/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
User facility personnel stated to a steris sales representative that they had been previously wearing gowns without a stomach barrier and have since received new ones with a barrier.Additionally, it was discovered that the employees subject of the reported event were not wearing gloves while handling prolystica hp enzymatic manual cleaner dye & fragrance.The prolystica hp enzymatic manual cleaner safety data sheet (sds) states, "personal protective equipment should be selected based upon the conditions under which this product is handled and used.Protective clothing, gloves, protective goggles.Wear rubber gloves or latex-free gloves, wear chemical splash goggles or safety glasses, wear suitable protective clothing." the prolystica hp enzymatic manual cleaner label states, "if skin irritation occurs, get medical attention." user facility personnel were counseled on the proper use of the prolystica, specifically the importance of wearing proper ppe.Udi related data clarification - the lot/serial number is unknown; therefore, the applicable production identifiers were not included in the mdr.No additional issues have been reported.
Event or Problem Description
The user facility reported that two employees experienced rashes after contacting prolystica hp enzymatic manual cleaner dye & fragrance.One employee did not seek medical treatment while the other went to the er and was given pepcid and prednisone.
Additional Manufacturer Narrative
Through additional follow-up, it was learned that the employees subject of the reported event weren't wearing the appropriate gloves while handling prolystica hp enzymatic manual cleaner.

• 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: 20713764
• Report Number: 1937531-2024-00006
• Device Sequence Number: 9903612
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 01/10/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown