MAUDE Adverse Event Report: UNOMEDICAL DEVICES S.A. DE C.V. INSET II; UNO INSET II 60/9 PINK TCAP 10PK INT

Model Number	1002822
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial and final mdr (b)(4).Device 3 of 3.
Event or Problem Description
Reference number (b)(4).Event occurred in the united states.It was reported that the patient experienced issue with three infusion sets on (b)(6) 2026 as the infusion set patch did not stick to the skin upon insertion.The patient replaced infusion sets and resumed insulin successfully.No further information available.

• Brand Name: INSET II
• Common Device Name: UNO INSET II 60/9 PINK TCAP 10PK INT
• Manufacturer (Section D): UNOMEDICAL DEVICES S.A. DE C.V.; ave. fomento industrial l9 m3; parque industrial del norte; reynosa, tamaulipas, c.p, 88736 ; MX 88736
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 24615491
• Report Number: 3003442380-2026-03115
• Device Sequence Number: 21366685
• Product Code: FPA
• UDI-Device Identifier: 05705244018273
• UDI-Public: 05705244018273
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K032854
• 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): 02/23/2026

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: 1002822
• Device Lot Number: 6014835
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2025
• 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 Age: 66 YR
• Patient Sex: Female