MAUDE Adverse Event Report: TRUSTEEL; CONTACT DETACH G29 60/6 TCAP

Lot Number UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.It was reported that the patient was hospitalized for diabetes ketoacidosis and infection around site on upper left thigh due to infusion set.Patient's blood glucose level was in the 300s mg/dl.The infusion set had been in use for less than one day and reverted to multiple daily injections due to infection/hospitalization.The patient was hospitalized for five days.No further information available.

• Brand Name: TRUSTEEL
• Type of Device: CONTACT DETACH G29 60/6 TCAP
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 8526590
• MDR Text Key: 142329516
• Report Number: 3003442380-2019-01278
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244014879
• UDI-Public: 05705244014879
• Combination Product (y/n): N
• PMA/PMN Number: K041545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial

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
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 03/25/2019
• Initial Date FDA Received: 04/18/2019
• Type of Device Usage: N
• Patient Sequence Number: 1