MAUDE Adverse Event Report: UNOMEDICAL A/S INSET GUARD; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MMT-242
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
Unomedical hereby submits this initial report as part of its complaint remediation activities conducted under a capa 2356421 and capa 2566479 in accordance with the fda action plan, which incorporates qp-ic-2026-0020 (ic retrospective complaint review) and qp-ic-2026-0024 (ic retrospective mdr review).This submission includes a retrospective reassessment of previously evaluated complaints.Unomedical is providing this supplemental information in accordance with the reporting requirements set forth in 21 cfr part 803.Any fields left blank indicate that the information is unknown, unavailable, or remains unchanged.E1: patient city: (b)(6).Patient country: united states.Additional information - this medical device report (mdr) is being submitted to include the below: h6: investigation results under type of investigation, investigation findings, investigation conclusions.H11: investigation summary.Complaint investigation results: review of complaint record database (b)(4) event description and all available information and it has been determined the complaint does not allege a product malfunction has occurred.Therefore, no further investigation is required.Conclusion of complaint investigation: no lot no.Was provided, however, as no product malfunction was alleged: no visual inspection is required to be performed.No retain sample testing is required to be conducted.No further assessment will be made regarding potential product performance issues, component integrity, or manufacturing defects.Corrective and preventive action (capa) determination: based on the available information, no further investigation is required nor capa plan is needed.The record will be closed and monitored through tracking and trending (monthly trips and alerts).Summary conclusion: based on the available information, the investigation has been performed, and the complaint could not be confirmed as analyzed.Therefore, the complaint is closed based on the event description and all information made available.Based on the available information, this event is deemed to be a death.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: 8021545.
Event or Problem Description
It was reported that the patient passed away due to an unknown cause on (b)(6) 2024.

• Brand Name: INSET GUARD
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1 - 3; osted; lejre 4320 ; DA 4320
• Manufacturer (Section G): UNOMEDICAL A/S; aaholmvej 1 - 3; osted; lejre 4320 ; DA 4320
• Manufacturer Contact: courtney smith ; aaholmvej 1 - 3; osted; lejre 4320 ; DA 4320 ; 6032470255
• MDR Report Key: 25481857
• Report Number: 8021545-2026-13647
• Device Sequence Number: 10513219
• Product Code: FPA
• UDI-Device Identifier: 05705244016323
• UDI-Public: 05705244016323
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K173879
• 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
• Report Date (Section B): 05/20/2026

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-242
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 06/12/2026
• 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: Death
• Patient Sex: Unknown