MAUDE Adverse Event Report: STERIS CORPORATION PROLYSTICA 2X CONCENTRATE ENZYMATIC PRESOAK AND CLEANER

Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	04/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility employee reported via chemtrec report that she "spilled" prolystica 2x concentrate enzymatic presoak and cleaner onto her right leg.The employee stated she experienced a "burning" sensation and washed the affected area for 15 minutes.It is unknown if the employee sought or received medical treatment.
Additional Manufacturer Narrative
Following the reported event, the user facility employee stated she contacted chemtrec for further guidance regarding the exposure to the prolystica 2x concentrate enzymatic presoak and cleaner.The employee subject of the reported event received a copy of the safety data sheet (sds).The safety data sheet states: first aid measures after skin contact- "immediately flush skin with plenty of water for at least 15 minutes.Remove immediately all contaminated clothing.Rinse skin with water.Get medical advice/attention." steris has not received additional information regarding the reported event.A follow-up report will be submitted should additional information become available.No additional issues have been reported.

• Brand Name: PROLYSTICA 2X CONCENTRATE ENZYMATIC PRESOAK AND CLEANER
• Common Device Name: PRESOAK AND 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: 19241583
• Report Number: 1937531-2024-00002
• Device Sequence Number: 7383834
• Product Code: FLG
• UDI-Device Identifier: 00724995087517
• UDI-Public: 00724995087517
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/03/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 05/03/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown