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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRUSTEEL UNO CONTACT DETACH G29 60/6TCAP 10PK INT

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TRUSTEEL UNO CONTACT DETACH G29 60/6TCAP 10PK INT Back to Search Results
Model Number 1002833
Device Problem Material Twisted/Bent (2981)
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 experienced high blood glucose levels of 501 mg/dl. On (b)(6) 2021, she arrived at the emergency room, and was subsequently admitted in the intensive care unit. Reportedly, the cannula was found to be bent upon removing from the body. During hospitalization, she was administered fluids of insulin, anti-nausea medication and an unknown medication intravenously (drug name unknown) as corrective treatment which resolved the issue. On (b)(6) 2021, she was released from the hospital with no permanent damage. No further information available.
 
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Brand NameTRUSTEEL
Type of DeviceUNO CONTACT DETACH G29 60/6TCAP 10PK INT
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key12518404
MDR Text Key272875775
Report Number3003442380-2021-00502
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
PMA/PMN Number
K041545
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial
Report Date 09/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1002833
Device Lot Number5345329
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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