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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL A/S MIO; UNO INSET II 46/6 SC1 BLUE MCAN
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UNOMEDICAL A/S MIO; UNO INSET II 46/6 SC1 BLUE MCAN Back to Search Results
Lot Number UNKNOWN
Medical Device Problem Code Leak/Splash (1354)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 04/26/2024
Type of Reportable Event Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the canada on 26-apr-2024, it was reported by the patient that four infusion set was leaking at 2am this morning from the site.No further information available.
 
Additional Manufacturer Narrative
Device 1 of 4.E1: patient city: (b)(6).
 
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Brand Name
MIO
Common Device Name
UNO INSET II 46/6 SC1 BLUE MCAN
Manufacturer (Section D)
UNOMEDICAL A/S
aaholmvej 1-3
osted
lejre, 4320
DA  4320
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key19402436
Report Number3003442380-2024-03749
Device Sequence Number20569390
Product Code FPA
UDI-Device Identifier05705244020306
UDI-Public05705244020306
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K160648
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source Foreign,Distributor
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 05/27/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/27/2024
Initial Report FDA Received Date05/27/2024
Was Device Evaluated by Manufacturer? (Y/N) No
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Unknown
Patient Sequence Number1
Patient SexUnknown
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