MAUDE Adverse Event Report: Medivators Inc Rapicide PA High-Level Disinfectant

Model Number	ML020117
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that an employee came into contact with rapicide pa high-level disinfectant and sustained a burn.It is unknown whether medical treatment was sought or administered.
Additional Manufacturer Narrative
The investigation into the reported event is in process.A follow-up report will be submitted when additional information becomes available.

• Brand Name: Rapicide PA High-Level Disinfectant
• Common Device Name: Rapicide PA High-level Disinfectant
• Manufacturer (Section D): Medivators Inc; 14605 28th avenue north; minneapolis MN 55447
• Manufacturer (Section G): Medivators Inc; 14605 28th avenue north; minneapolis MN 55447
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; +1(440)259-7401
• MDR Report Key: 50098269
• Report Number: 2150060-2026-00031
• Device Sequence Number: 21412030
• Product Code: FEB
• UDI-Device Identifier: 00724995245962
• UDI-Public: (01)00724995245962(11)260504(17)271102(10)689177
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K082988
• 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): 07/31/2026

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: ML020117
• Device Catalogue Number: ML020117
• Device Lot Number: (10)689177
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2026
• Initial Report FDA Received Date: 07/31/2026
• Date Device Manufactured: 05/04/2026
• 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