MAUDE Adverse Event Report: UNOMEDICAL DEVICES S.A. DE C.V. CONTACT DETACH; UNO CONTACT DETACH G29 46/6 SC1 MIMX

Model Number	MMT-862A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypoglycemia (1912); Loss of consciousness (2418)
Date of Event	02/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Reference number (b)(4).Event occured in germany.It was reported that the patient was hospitalized and subsequently admitted to the intensive care unit (icu) on (b)(6) 2026 due to low blood glucose (17 mg/dl).The patient was unconscious during the event and was treated with glucagon.Following stabilization, insulin was administered via infusion.The duration of hospitalization was greater than 24 hours.No further information is available.
Additional Manufacturer Narrative
E1: patient city: (b)(6).Patient country: germany.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.

• Brand Name: CONTACT DETACH
• Common Device Name: UNO CONTACT DETACH G29 46/6 SC1 MIMX
• 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: 24710050
• Report Number: 3003442380-2026-04771
• Device Sequence Number: 20265534
• Product Code: FPA
• UDI-Device Identifier: 05705244019287
• UDI-Public: 05705244019287
• 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): 02/28/2026

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-862A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2026
• Initial Report FDA Received Date: 03/30/2026
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown