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

Model Number	1C2408
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Headache (1880)
Date of Event	09/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Through follow-up, it was determined that the user facility was a new user to the prolystical hp enzymatic manual cleaner.The prolystica hp enzymatic manual cleaner safety data sheet states, "avoid all unnecessary exposure.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.Wear chemical splash goggles or safety glasses.Wear suitable protective clothing.Work in well-ventilated zones or use proper respiratory protection.In fine dispersion/spraying/misting: wear suitable respiratory equipment." the lot history record was reviewed.No abnormalities were noted.There have been no other complaints associated with this lot.The customer stated that they could not use the proper ppe as indicated in the safety data sheet.It is likely that user error caused or contributed to the reported event.The customer has elected to discontinue use of the prolystica hp enzymatic manual cleaner.No additional issues have been reported.
Event or Problem Description
The user facility reported that 5 employees experienced headaches when using prolystica hp enzymatic manual cleaner.The employees self-treated with advil and tylenol.
Additional Manufacturer Narrative
Through follow-up with the user facility, it was determined that the employees were wearing ppe at the time of the reported event.
Additional Manufacturer Narrative
Udi related data quality updates only - alignment with gudid.

• Brand Name: PROLYSTICA
• Common Device Name: PROLYSTICA HP ENZYMATIC MANUAL 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: 17885376
• Report Number: 1937531-2023-00003
• Device Sequence Number: 15202273
• Product Code: FLG
• UDI-Device Identifier: 00724995211561
• UDI-Public: (01)00724995211561(17)250501(10)324094
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 10/06/2023

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 Expiration Date: 05/01/2025
• Device Model Number: 1C2408
• Device Catalogue Number: 1C2408
• Device Lot Number: (10)324094
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2023
• Supplement Date Received by Manufacturer: 09/11/2023; Not provided
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 11/01/2023; 01/24/2025
• Date Device Manufactured: 05/04/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown