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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 NameMIO¿
Type of DeviceINSET 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
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
0 Patients were Involved in the Event:
Date FDA Received02/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/01/2021
Device Lot Number5248536
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/05/2019
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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