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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSET¿II; INSET II 60/9 PINK
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INSET¿II; INSET II 60/9 PINK 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 (b)(6).The patient reported that in one of the infusion sets, the tubing detached while the patient was sleeping.No further information available.
 
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Brand Name
INSET¿II
Common Device Name
INSET II 60/9 PINK
MDR Report Key8447342
Report Number3003442380-2019-00689
Device Sequence Number19586722
Product Code FPA
UDI-Device Identifier05705244007673
UDI-Public05705244007673
Combination Product (Y/N)N
PMA/510(K) Number
K032854
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 02/06/2017
Initial Report FDA Received Date03/25/2019
Patient Sequence Number1
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