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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, balloon, transcervical
Product CodeMKN
Device Class 3

MDR Year MDR Reports MDR Events
2014 7 7
2015 5 5
2016 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Pressure Problem 3 3
Leak/Splash 3 3
Temperature Problem 3 3
Device Operates Differently Than Expected 2 2
Inflation Problem 2 2
Failure to Cycle 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure To Adhere Or Bond 1 1
Difficult to Open or Close 1 1
Defective Device 1 1
Overheating of Device 1 1
Break 1 1
Sticking 1 1
Loss of Power 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 5 5
No Known Impact Or Consequence To Patient 3 3
No Patient Involvement 2 2
No Consequences Or Impact To Patient 2 2
Complaint, Ill-Defined 1 1

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