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	Chemical Exposure (2570)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Steris has made multiple attempts to obtain additional information regarding the reported event.A follow-up report will be submitted should 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.No additional issues have been reported.
Event or Problem Description
The user facility contacted steris as part of their investigation into "one of our employees recently reported some health concerns that s/h believes may be related to an exposure in the workplace".It is unknown if medical treatment was sought or administered.
Additional Manufacturer Narrative
Through follow-up with user facility personnel, it was discovered that the employee involved in the reported event was performing maintenance to repair a ceiling tile light when they observed water which had a strong odor.The employee experienced respiratory symptoms and skin irritation; however, they did not seek medical treatment.The employee was repairing the ceiling tile light as part of a facility draining issue.The exact cause of the reported event is unknown.The employee subject of the reported event was provided with a copy of the safety data sheet.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.

• Brand Name: RAPICIDE PA HIGH-LEVEL DISINFECTANT
• Common Device Name: RAPICIDE
• 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 ; 4402597401
• MDR Report Key: 22679574
• Report Number: 2150060-2025-00023
• Device Sequence Number: 9472983
• Product Code: FEB
• UDI-Device Identifier: 00677964063619
• UDI-Public: (01)00677964063619
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 07/31/2025

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: 07/01/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 11/06/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown