MAUDE Adverse Event Report: Unomedical Devices S.A de C.V Inset II; Set, Administration, Intravascular

Model Number	MMT-943600
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	07/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient was hospitalized for seven days due to high blood glucose on (b)(6) 2026 and was addressed by intravenous insulin drip.
Additional Manufacturer Narrative
Validation error was observed for the outcome "required intervention to prevent permanent impairment/damage (devices)." the outcome was removed from the outcomes attributed to ae tab; however, the outcome remains documented within the complaint information.The case was updated and resubmitted e1: (b)(6).Based on the available information, this event is deemed to be a serious injury.Request was performed for additional information including lot number; however, lot number was not provided.A complaint investigation was initiated under complaint investigation.Unfortunately, no specific lot number was identified, which limits the ability to trace or analyze a particular item.Investigation in progress.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: 8021545.Manufacturing site: 3003442380.

• Brand Name: Inset II
• Common Device Name: Set, Administration, Intravascular
• Manufacturer (Section D): Unomedical Devices S.A de C.V; ave.fomento industrial l9 m3; parque industrial del norte; reynosa,tamps. 88736 ; MX 88736
• Manufacturer (Section G): Unomedical Devices S.A de C.V; ave.fomento industrial l9 m3; parque industrial del norte; reynosa,tamps. 88736 ; MX 88736
• Manufacturer Contact: pamela meadows ; aaholmvej 1 - 3; osted; lejre 4320 ; DA 4320 ; +1(603)247-0255
• MDR Report Key: 50344839
• Report Number: 3003442380-2026-78434
• Device Sequence Number: 6024283
• Product Code: FPA
• UDI-Device Identifier: 05705244007512
• UDI-Public: 05705244007512
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K160648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2026

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: MMT-943600
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2026
• 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