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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSET¿30; INSET 30 60/13 GREY
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INSET¿30; INSET 30 60/13 GREY Back to Search Results
Lot Number 5172228
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, the hose was not glued to the connector part.No further information available.
 
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Brand Name
INSET¿30
Common Device Name
INSET 30 60/13 GREY
MDR Report Key8265837
Report Number3003442380-2019-00242
Device Sequence Number13984851
Product Code FPA
UDI-Device Identifier05705244007123
UDI-Public05705244007123
Combination Product (Y/N)N
PMA/510(K) Number
K061374
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 Date01/01/2020
Device Lot Number5172228
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/04/2017
Initial Report FDA Received Date01/21/2019
Patient Sequence Number1
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