MAUDE Adverse Event Report: SURE-T PARADIGM; UNO CONTACT DETACH G29 80/6 SC1 MIMX

Model Number MMT866A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Tissue Breakdown (2681)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in canada.On (b)(6) 2021, the patient reported that the infusion set accidentally pulled off from the body.Also, the needle looked shorter and seemed that the needle might have broken off at the site due to which the patient had to be hospitalized on the date of this report on ((b)(6) 2021).The needle was inserted on the right side of patient's abdomen.Moreover, the infusion set was inserted for three days (on (b)(6) 2021).Moreover, the blood glucose level of the patient at the time of hospitalization was 12.5 mmol/l.Further, on the same date of hospitalization, the needle was removed and it was not in the skin.No further information was available.

• Brand Name: SURE-T PARADIGM
• Type of Device: UNO CONTACT DETACH G29 80/6 SC1 MIMX
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 16383748
• MDR Text Key: 309635743
• Report Number: 3003442380-2023-00162
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244019348
• UDI-Public: 05705244019348
• Combination Product (y/n): Y
• PMA/PMN Number: K160648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 10/01/2023
• Device Model Number: MMT866A
• Device Lot Number: 5339097
• Date Manufacturer Received: 02/03/2023
• Patient Sequence Number: 1