MAUDE Adverse Event Report: UNOMEDICAL DEVICES S.A DE C.V COMFORT; Set, Administration, Intravascular

Model Number	MMT-377A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	05/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information, this event is deemed to be a reportable serious injury.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Reporting site: 8021545.Manufacturing site: 3003442380.
Event or Problem Description
It was reported that patient experienced hypoglycemia event on (b)(6) 2026 and low blood glucose and treated with eating orange and nuts.
Event or Problem Description
To date, additional patient or event details were received which have been added in h11 (addl mfg narrative).
Additional Manufacturer Narrative
Correction: this mdr is being submitted to correct the submitted expiration date under d4 and manufacturing date under h4 and initial report sent to fda under report initial information and initial report sent to fda e4.Additional information - this electronic medical device report (emdr) is being submitted to include the below: h6: investigation results under type of investigation, investigation findings, investigation conclusions h11: investigation summary complaint investigation results a complaint investigation was conducted based on the event description and the assigned malfunction code no malfunction based on complaint information based on the available information, the event is consistent with misuse, user-related factors, or no malfunction alleged.In accordance with appendix of work instruction (wi) complaint handling, the need for additional investigation activities, including product testing, or electronic quality management system (eqms) search, was evaluated and determined not to be warranted for this record.However, as a lot number was provided and the event involved a serious injury, a batch record / medical device file review was conducted for lot 6017201 to assess any potential manufacturing-related issues.Batch record / medical device file review: the batch record / medical device file was reviewed.All required in-process and final tests were completed and met specified requirements.No deviations were identified, and no related maintenance activities were recorded.Conclusion: batch record / medical device file review supports compliance with manufacturing and quality requirements; no issues noted.Complaint unconfirmed: following investigation the reported failure could not be confirmed for this complaint.Corrective and preventive action (capa) determination assessment - conclusion summary of complaint investigation: based on the investigation, no further investigation is required.The record will be closed and monitored through tracking and trending per work instruction (wi) (monthly trips and alerts).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: COMFORT
• 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: 25500653
• Report Number: 3003442380-2026-34377
• Device Sequence Number: 10552930
• Product Code: FPA
• UDI-Device Identifier: 05705244019522
• UDI-Public: 05705244019522
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2026

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-377A
• Device Lot Number: 6017201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2026
• Supplement Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 06/15/2026
• Supplement Report FDA Received Date: 08/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2026
• 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