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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIO¿; INSET II 80/6 PCC GREY
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MIO¿; INSET II 80/6 PCC GREY Back to Search Results
Lot Number 5240402
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.The patient reported that the tubing came apart and the pump was dropped with the set-in place.There was leakage on her set at the adhesive.No further information available.
 
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Brand Name
MIO¿
Common Device Name
INSET II 80/6 PCC GREY
MDR Report Key8489915
Report Number3003442380-2019-01020
Device Sequence Number1634280
Product Code FPA
UDI-Device Identifier05705244007796
UDI-Public05705244007796
Combination Product (Y/N)N
PMA/510(K) Number
K160648
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial
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
Operator of Device No Information
Device Expiration Date05/01/2021
Device Lot Number5240402
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/22/2019
Initial Report FDA Received Date04/07/2019
Patient Sequence Number1
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