MAUDE Adverse Event Report: UNOMEDICAL A/S SILHOUETTE PARADIGM; UNO COMFORT SHORT 110/13 PCC MINI

Model Number	MMT-382
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: patient city (b)(6).Patient country mexico.
Event or Problem Description
Reference number (b)(4).Event occurred in mexico.On 21 -aug-2024, it was reported that the patient encountered infusion set tubing detachement the site of insertion was gluteous.The infusion set was in use for 2 days.No further information available.
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Additional information - this mdr is being submitted to include the below: h6: investigation results under type of investigation, investigation findings, investigation conclusions.H11: investigation summary.Per revision 21 of procedure (b)(4), a child investigation is not required to document the dhr review for a type 2 reportable complaint.However, the child was created to allow the parent record to advance to review and summary.Since it was created, the dhr review was documented within the child.Complaint investigation results: a complaint investigation has been initiated under complaint investigation child record (b)(4).The batch 5406384, in question was manufactured at the reynosa site.Device history record (dhr) review: the lot 5406384 was manufactured according to the work instruction (wi) version 13 and packaged in the machine multivac 10 on 31-oct-2022, with a total of (b)(4) units.Gluing tube the sub-assembly, gluing tube of the lot 5409108 was manufactured according to the wi version 8 and manufactured in the machine lc02, on 02-nov-2022, with a total of (b)(4) units.The sub-assembly, gluing tube of the lot 5406922 was manufactured according to the wi version 8 and manufactured in the machine lc01, on 26-oct-2022, with a total of (b)(4) units.Review of the dhr showed that a non-conformance (nc) was raised due to planned deviation: use a different cartridge presentation for glue.This nc is not related to claimed malfunction.Conclusion summary of complaint investigation: one nonconformance (nc) was raised and found unrelated to the reported malfunction code, no further actions are required.This complaint will not require further root cause investigation nor corrective and preventive action (capa) plan.Therefore, this issue will be monitored through the post market surveillance activities.

• Brand Name: SILHOUETTE PARADIGM
• Common Device Name: UNO COMFORT SHORT 110/13 PCC MINI
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 20331085
• Report Number: 3003442380-2024-27698
• Device Sequence Number: 8003647
• Product Code: FPA
• UDI-Device Identifier: 05705244009165
• UDI-Public: 05705244009165
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/29/2025
• Device Model Number: MMT-382
• Device Lot Number: 5406384
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2024
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2022
• 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