MAUDE Adverse Event Report: UNOMEDICAL A/S CONTACT DETACH; UNO CONTACT DETACH G29 60/6 TCAP 10PK INT

Model Number	1002833
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	02/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Reference number (b)(4).Event occurred in the united states.It was reported that the patient experienced occlusion event as patient used the infusion set for more than 48 hours on (b)(6) 2026 which leads to high blood glucose levels and was treated by correction injection via multiple daily injections (mdi).No further information available.

• Brand Name: CONTACT DETACH
• Common Device Name: UNO CONTACT DETACH G29 60/6 TCAP 10PK INT
• Manufacturer (Section D): UNOMEDICAL A/S; 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: 24742553
• Report Number: 3003442380-2026-06298
• Device Sequence Number: 17266036
• Product Code: FPA
• UDI-Device Identifier: 05705244018426
• UDI-Public: 05705244018426
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K041545
• 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): 03/02/2026

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: Lay User/Patient
• Device Model Number: 1002833
• Device Lot Number: 6015693
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male