MAUDE Adverse Event Report: STERIS Corporation Prolystica; Prolystica 2X Concentrate Neutral Detergent

Model Number	1C3208
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	03/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that an employee was exposed to prolystica 2x concentrate neutral detergent for approximately two years, and, per the employee, their physician believes they have become "sensitized" to the product.The employee sought medical treatment and is currently under the care of an orthopedic surgeon.
Additional Manufacturer Narrative
The investigation into the reported event is in process.A follow-up report will be submitted when additional information becomes available.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: Prolystica 2X Concentrate Neutral Detergent
• 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 ; +1(440)259-7401
• MDR Report Key: 50075173
• Report Number: 1937531-2026-00006
• Device Sequence Number: 16015797
• Product Code: FLG
• UDI-Device Identifier: 00724995090968
• UDI-Public: (01)00724995090968
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (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): 07/29/2026

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: 1C3208
• Device Catalogue Number: 1C3208
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 07/29/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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