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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 Detachment of Device or Device Component (2907)
Patient Problem Hypoglycemia (1912)
Event Type  malfunction  
Event Description
Unomedical reference number (b)(4). Event occurred in (b)(6). It was reported that patient's infusion set's tubing on the connector was giving issues as it broke off from the site. Her blood glucose level was 4. 6 mmol/l at the time of incident. Moreover, she did not notice any damage to the infusion sets when the package was first opened. Further, they replaced the infusion set and insulin was resumed successfully. 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 Key11299792
MDR Text Key231157049
Report Number3003442380-2021-00139
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
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1002833
Device Lot Number5314383
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/27/2021
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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