MAUDE Adverse Event Report: Midwest Products and Engineering, Inc. INTELLIO

Model Number	2111023
Medical Device Problem Codes	Device Slipped (1584); Misassembly by Users (3133); Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2026
Type of Reportable Event	Malfunction

• Brand Name: INTELLIO
• Common Device Name: INTELLIO
• Manufacturer (Section D): Midwest Products and Engineering, Inc.; 10597 w. glenbrook ct.; milwaukee WY 53224
• Manufacturer (Section G): Midwest Products and Engineering, Inc.; 10597 w. glenbrook ct.; milwaukee WY 53224
• Manufacturer Contact: monique-elise alamina ; 10597 w. glenbrook ct.; milwaukee, WY 53224
• MDR Report Key: 50843138
• Report Number: 3003500271-2026-00001
• Device Sequence Number: 9957628
• Product Code: NBH
• UDI-Device Identifier: 00197644606863
• UDI-Public: 00197644606863
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2111023
• Device Catalogue Number: 72205729
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/21/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown