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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUICK-SET PARADIGM UNO QUICK-SET 60/6 PCC MECA

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QUICK-SET PARADIGM UNO QUICK-SET 60/6 PCC MECA Back to Search Results
Model Number MMT-399
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. On (b)(6) 2021, it was reported that the patient faced issues with the infusion set three times last (b)(6) and four times last (b)(6). Therefore, on (b)(6) 2021, the patient experienced high blood glucose level of 975 mg/dl and diabetic ketoacidosis due to which he was subsequently hospitalized. During hospitalization, they found that the cannula was bent back then, when the set was removed from him. Moreover, he had the covid vaccine, a day before he was hospitalized, and they were suspecting that it may be a side effect of the vaccine too. The patient did not receive any alerts back then even the cannula was bent. The patient stayed in the intensive care unit for four days and for two more days for observation. Unomedical do not see bent/kinking as being related to human factors, but rather as a training issue including correct choices of insertion sites and infusion sets and cannula length. Furthermore, the soft cannula is a flexible material that during use and upon removal can bend slightly. No further information available.
 
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Brand NameQUICK-SET PARADIGM
Type of DeviceUNO QUICK-SET 60/6 PCC MECA
Manufacturer Contact
aaholmvej 1-3
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lejre, 4320
MDR Report Key11899815
MDR Text Key253120325
Report Number3003442380-2021-00264
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
PMA/PMN Number
K160648
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 Received05/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-399
Device Lot Number5317586
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/21/2021
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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