MAUDE Adverse Event Report: STERIS CORPORATION PROLYSTICA; CLEANER

Model Number	1C2408
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Headache (1880)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that two employees were experiencing a headache when using prolystica hp enzymatic manual cleaner.It is unknown if medical treatment was sought or administered.
Additional Manufacturer Narrative
It was confirmed that proper respiratory protection was worn at the time of the event.A steris clinical educator arrived onsite and determined that there was inadequate ventilation in the space where the event took place.The prolystica hp enzymatic manual cleaner safety data sheet states, "avoid breathing mist, spray, vapors.In case of inadequate ventilation, wear respiratory protection.Provide good ventilation in process area to prevent formation of vapor.Avoid all eye and skin contact and do not breathe vapor and mist.Ensure adequate ventilation.Control airborne concentrations below the exposure limits.Work in well-ventilated zones or use proper respiratory protection.In fine dispersion/spraying/misting: wear suitable respiratory equipment." user facility personnel were counseled on the importance of proper ventilation while using this product.No additional issues reported.

• 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: 20158008
• Report Number: 1937531-2024-00005
• Device Sequence Number: 4237035
• Product Code: FLG
• UDI-Device Identifier: 00724995211561
• UDI-Public: (01)00724995211561
• 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): 09/06/2024

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: 1C2408
• Device Catalogue Number: 1C2408
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 09/06/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown