MAUDE Adverse Event Report: MEDIVATORS, INC. RAPICIDE OPA/28 HIGH LEVEL DISINFECTANT

Model Number	ML02-0127
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Headache (1880)
Date of Event	01/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via chemtrec report that an individual "developed a headache" and "irritation to her uvula" from ingestion exposure to rapicide opa high level disinfectant.The individual sought medical treatment, but it is unknown if treatment was administered.
Additional Manufacturer Narrative
The report did not identify the contact information or location of the user of the product in question therefore, additional information could not be obtained.To-date we have not been informed of this event directly from the user.Should additional information become available a follow-up report will be submitted.

• Brand Name: RAPICIDE OPA/28 HIGH LEVEL DISINFECTANT
• Common Device Name: DISINFECTANT
• Manufacturer (Section D): MEDIVATORS, INC.; 14605 28th avenue n; plymouth MN 55447
• Manufacturer (Section G): MEDIVATORS, INC.; 14605 28th avenue n; plymouth MN 55447
• Manufacturer Contact: daniel davy ; 9800 59th avenue n; plymouth, MN 55442 ; 4403927453
• MDR Report Key: 16426588
• Report Number: 2150060-2023-00014
• Device Sequence Number: 2644977
• Product Code: MED
• UDI-Device Identifier: 00677964054266
• UDI-Public: 00677964054266
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Type of Report: Initial
• Report Date (Section B): 02/23/2023

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: ML02-0127
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown