MAUDE Adverse Event Report: MEDIVATORS INC. MINNCARE HD; MINNCARE DISINFECTANT

Model Number	3029764
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Steris contacted the user facility to obtain additional information regarding the reported event.User facility personnel stated that the employee subject of the reported event was attempting to replace the minncare when the reported inhalation/irritation occurred.It was reported that the employee's symptoms subsided after 5 minutes.The ifu states, "if inhaled move person to fresh air.If person is not breathing, call 911 or an ambulance, then give artificial respiration, preferably mouth-to-mouth, if possible, call a poison control center or doctor for further treatment advice." steris offered in-service training on the proper use and handling for minncare high-level disinfectant however, the user facility declined.No additional issues have been reported.Udi related data clarification - the lot/serial number is unknown, therefore, the applicable production identifiers were not included in the mdr.
Event or Problem Description
The user facility reported via chemtrec report that an employee experienced an "altered level of consciousness" due to inhalation exposure while handling minncare high-level disinfectant.The employee immediately removed himself from the area into fresh air and contacted poison control.No medical treatment was administered.

• Brand Name: MINNCARE HD
• Common Device Name: MINNCARE 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: 20878595
• Report Number: 2150060-2024-00058
• Device Sequence Number: 20784626
• Product Code: NIH
• UDI-Device Identifier: 00724995223298
• UDI-Public: (01)00724995223298
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 12/09/2024

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
• Device Model Number: 3029764
• Device Catalogue Number: 3029764
• 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: 11/10/2024
• Initial Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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