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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIO¿; INSET II 60/6 PCC PINK

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MIO¿; INSET II 60/6 PCC PINK Back to Search Results
Lot Number 5248536
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Diabetic Ketoacidosis (2364)
Event Type  Injury  
Event Description
Unomedical reference number (b)(4).Event occurred in the united states.The patient reported that she was hospitalized due to diabetic ketoacidosis.No further information available.
 
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Brand Name
MIO¿
Type of Device
INSET II 60/6 PCC PINK
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key8342405
MDR Text Key136232653
Report Number3003442380-2019-00550
Device Sequence Number1
Product Code FPA
UDI-Device Identifier05705244007697
UDI-Public05705244007697
Combination Product (y/n)N
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
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date07/01/2021
Device Lot Number5248536
Initial Date Manufacturer Received 02/05/2019
Initial Date FDA Received02/15/2019
Type of Device Usage N
Patient Sequence Number1
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