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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRUSTEEL; UNO CONTACT DETACH G29 80/6TCAP 10PK INT
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TRUSTEEL; UNO CONTACT DETACH G29 80/6TCAP 10PK INT Back to Search Results
Lot Number UNKNOWN
Device Problem Infusion or Flow Problem (2964)
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 in her first trimester of pregnancy, and she faced an insulin flow block issue which she kept on getting since (b)(6) 2024, which led to high blood glucose level.Therefore, they tried to treat it with correction injection via multiple daily injection, but on (b)(6) 2024, the patient first went to the emergency room and was subsequently hospitalized.Her highest blood glucose level was 1027 mg/dl and had diabetes burn out.Moreover, the site location was her legs and arms, but she was strictly recommended to apply it on her stomach by the healthcare professional.Further, she was transferred to the intensive care unit.During hospitalization, the patient received fluids of saline, insulin, and unspecified medication (drug name unknown) intravenously.On (b)(6) 2024, the patient was released from the hospital with no permanent damage.No further information available.
 
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Brand Name
TRUSTEEL
Type of Device
UNO CONTACT DETACH G29 80/6TCAP 10PK INT
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key19039565
MDR Text Key339319639
Report Number3003442380-2024-00217
Device Sequence Number1
Product Code FPA
UDI-Device Identifier05705244018457
UDI-Public05705244018457
Combination Product (y/n)N
PMA/PMN Number
K041545
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 04/04/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Lot NumberUNKNOWN
Date Manufacturer Received04/02/2024
Patient Sequence Number1
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