MAUDE Adverse Event Report: UNOMEDICAL DEVICES S.A. DE C.V. COMFORT; UNO CONFORT 60/17 PCC MINI

Model Number	MMT-378
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial and final mdr (b)(4) -mdr 3003442380-2025-19014- device 4 of 4.Since no lot number is available, a detailed investigation, tests on reference samples or batch review cannot be conducted.Therefore, this complaint will be closed, this issue will be monitored through post marketing surveillance (pms) product trends and malfunction.If any trends are picked up, this will flag on the trips and alerts according to the on market quality review (omqr) procedure.
Event or Problem Description
Reference number (b)(4).Event occured in the united states.It was reported that patient faced four infusion sets tubing detachment events on (b)(6) 2025.The patient reported that infusion set was just used it today but the infusion set are old ones which are around 5 years.The insertion site was abdomen.No further information is available.

• Brand Name: COMFORT
• Common Device Name: UNO CONFORT 60/17 PCC MINI
• Manufacturer (Section D): UNOMEDICAL DEVICES S.A. DE C.V.; ave. fomento industrial l9 m3; parque industrial del norte; reynosa, tamaulipas, c.p, mexico 88736 ; MX 88736
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, denmark 4320
• MDR Report Key: 24112331
• Report Number: 3003442380-2025-19014
• Device Sequence Number: 17602447
• Product Code: FPA
• UDI-Device Identifier: 05705244008755
• UDI-Public: 05705244008755
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162812
• 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): 12/24/2025

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-378
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2025
• Initial Report FDA Received Date: 01/19/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown