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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, cystometric, hydraulic
Regulation Description Urodynamics measurement system.
Product CodeFEN
Regulation Number 876.1620
Device Class 2


Premarket Reviews
ManufacturerDecision
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL ENGINEERING CORP.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
SURGITEK
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Deflation issue 7
Leak 6
No flow 5
Infusion or flow issue 3
Blocked connection 3
Calibration issue 3
Defective component 3
Obstruction within device 3
Blockage within device or device component 3
Break 2
Disconnection 2
Display misread 1
Inflation issue 1
Crack 1
Loss of or failure to bond 1
Defective item 1
Device or device fragments location unknown 1
No device output 1
Difficult to Program or Calibrate 1
Incorrect or inadequate result 1
Sticking 1
Connection issue 1
Detachment of device or device component 1
Device operates differently than expected 1
Difficult to open or close 1
Total Device Problems 54

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0


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