MAUDE Adverse Event Report: MEDIVATORS INC. RAPICIDE PA HIGH-LEVEL DISINFECTANT

Model Number	ML02-0117
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Eye Irritation (4803)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the user flushed their eyes with water for at least 15 minutes, then was reported to be "not experiencing symptoms." multiple attempts were made to obtain additional information from the user facility; however, no additional information was provided.The rapicide labeling states, "wear protective gloves/eye protection/face protection.If in eyes: rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do.Continue rinsing.Immediately call a poison center/doctor." udi related data clarification - the lot number are unknown; therefore, the production identifiers were not included in the mdr.No additional issues have been reported.
Event or Problem Description
The user facility reported via chemtrec report that an employee's eyes were exposed to rapicide pa high-level disinfectant.Chemtrec offered medical assistance, and a copy of the safety data sheet.

• Brand Name: RAPICIDE PA HIGH-LEVEL DISINFECTANT
• Common Device Name: RAPICIDE PA HIGH-LEVEL DISINFECTANT
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 21953904
• Report Number: 2150060-2025-00013
• Device Sequence Number: 8553600
• Product Code: FEB
• UDI-Device Identifier: 00677964063619
• UDI-Public: (01)00677964063619
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K082988
• 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
• Report Date (Section B): 05/02/2025

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: ML02-0117
• Device Catalogue Number: ML020117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 05/02/2025
• 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