MAUDE Adverse Event Report: UNOMEDICAL UM-D CONTACT DETACH; UNO CONTACT DETACH G29 60/8 PCC MIMX

Model Number	MMT-874
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	02/23/2026
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 was hospitalized due to hypoglycemia on (b)(6) 2026.The patients blood glucose level was 20 mg/dl.No further information is available.
Additional Manufacturer Narrative
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.

• Brand Name: CONTACT DETACH
• Common Device Name: UNO CONTACT DETACH G29 60/8 PCC MIMX
• Manufacturer (Section D): UNOMEDICAL UM-D; 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: 24701182
• Report Number: 3003442380-2026-04752
• Device Sequence Number: 10046724
• Product Code: FPA
• UDI-Device Identifier: 05705244005792
• UDI-Public: 05705244005792
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: 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-874
• 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: 03/26/2026
• 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
• Patient Sex: Unknown