MAUDE Adverse Event Report: UNOMEDICAL A/S SURE-T PARADIGM; UNO CONTACT DETACH G29 80/10 PCC MIMX

Model Number	MMT-886
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	07/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: patient city: (b)(6).Patient country : united states.
Event or Problem Description
Reference number (b)(4).Event occurred in the united states.It was reported that patient complained about infusion set fell off during shower due to tape not sticking on (b)(6) 2024.No further information available.

• Brand Name: SURE-T PARADIGM
• Common Device Name: UNO CONTACT DETACH G29 80/10 PCC MIMX
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 19916403
• Report Number: 8021545-2024-03001
• Device Sequence Number: 20672878
• Product Code: FPA
• UDI-Device Identifier: 05705244006034
• UDI-Public: 05705244006034
• 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): 07/08/2024

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 Model Number: MMT-886
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 08/06/2024
• 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
• Patient Sex: Unknown