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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIO¿; INSET II 80/6 PCC BLUE
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MIO¿; INSET II 80/6 PCC BLUE Back to Search Results
Lot Number UNKNOWN
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.Reportedly, the patient was in a hurry getting her wheel chair to toilet and when she pulled down the pants tubing came off.No further information available.
 
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Brand Name
MIO¿
Common Device Name
INSET II 80/6 PCC BLUE
MDR Report Key8221183
Report Number3003442380-2019-00121
Device Sequence Number13522294
Product Code FPA
UDI-Device Identifier05705244007734
UDI-Public05705244007734
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 Lot NumberUNKNOWN
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/08/2016
Initial Report FDA Received Date01/07/2019
Patient Sequence Number1
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