MAUDE Adverse Event Report: UNOMEDICAL A/S INSET GUARD; UNO EWIS BLUE 60/9 HCAP 3-PK INT

Model Number	MMT-441AH
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Reference number (b)(4).Event occurred in canada.It was reported that the patient faced infusion set leakage event on (b)(6) 2026.The leakage was at the site.The infusion set was in use for two days.The patient replaced the infusion set and resumed insulin delivery successfully.No further information available.

• Brand Name: INSET GUARD
• Common Device Name: UNO EWIS BLUE 60/9 HCAP 3-PK INT
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 24589325
• Report Number: 8021545-2026-01220
• Device Sequence Number: 21142218
• Product Code: FPA
• UDI-Device Identifier: 05705244023284
• UDI-Public: 05705244023284
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K210544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/25/2026

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
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-441AH
• Device Lot Number: 6015400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown