MAUDE Adverse Event Report: TRUSTEEL; UNO CONTACT DETACH G29 60/8TCAP 10PK INT

Model Number 1002835

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Unspecified Infection (1930); Tissue Breakdown (2681)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.It was reported that on (b)(6) 2022, the patient's infusion set site got infected, as a piece of the set broke off and was under the skin.She had infection and severe irritation because her cannula broke off from the infusion set and became lodged in her skin.However, they replaced the infusion set and insulin was resumed successfully.Consequently, on (b)(6) 2022, she went to the emergency room and was hospitalized.She stayed there for 3 days and 2 nights.During hospitalization, she was administered fluids of saline, insulin, and some unspecified drug intravenously as corrective treatment which resolved the issue.Moreover, she also took vancomycin via her health care professional's prescription, but she had an allergic reaction to the medication.Further, she also received an ultrasound which revealed a foreign body (the needle) in her skin and led to surgery.Reportedly, surgery was performed to remove a cannula needle (from an infusion set) which became lodged in her skin for multiple days after infusion set removal.On (b)(6) 2022, she was released from the hospital and had no permanent damage.No further information available.

• Brand Name: TRUSTEEL
• Type of Device: UNO CONTACT DETACH G29 60/8TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 14109989
• MDR Text Key: 289252593
• Report Number: 3003442380-2022-00547
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244018488
• UDI-Public: 05705244018488
• Combination Product (y/n): Y
• PMA/PMN Number: K041545
• 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: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1002835
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 04/05/2022
• Patient Sequence Number: 1