MAUDE Adverse Event Report: MEDIVATORS INC. INTERCEPT DETERGENT

Model Number	ML02-0106
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Eye Irritation (4803)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility reported that the lot number was unknown.The intercept detergent safety data sheet states, "precautionary statements: wear protective gloves/protective clothing/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.If eye irritation persists: get medical advice/attention." following the reported event, the user facility was provided with a copy of the safety data sheet for intercept detergent.No additional issues have been reported.Udi related data clarification - the lot 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 was pouring intercept detergent into a sink when the product splashed past their eye protection, causing eye irritation.The employee immediately flushed their eyes with water for 10-15 minutes.The employee went to be evaluated at an outpatient center; however, their symptoms resolved and no additional medical treatment was required.

• Brand Name: INTERCEPT DETERGENT
• Common Device Name: DETERGENT
• 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: 24942326
• Report Number: 2150060-2026-00015
• Device Sequence Number: 8946941
• Product Code: MNL
• UDI-Device Identifier: 00677964043086
• UDI-Public: (01)00677964043086
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 04/21/2026

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: ML02-0106
• 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: 03/23/2026
• Initial Report FDA Received Date: 04/21/2026
• 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