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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device negative pressure wound therapy powered suction pump
Regulation Description Powered suction pump.
Definition For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The Device is indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
Product CodeOMP
Regulation Number 878.4780
Device Class 2


Premarket Reviews
ManufacturerDecision
ARGENTUM MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ATMOS INC.
  SUBSTANTIALLY EQUIVALENT 1
BLUE SKY MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 5
GENADYNE BIOTECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 7
INNOVATIVE THERAPIES, INC.
  SUBSTANTIALLY EQUIVALENT 4
KINETIC CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 23
MEDELA
  SUBSTANTIALLY EQUIVALENT 6
MOLNLYCKE HEALTH CARE
  SUBSTANTIALLY EQUIVALENT 1
PREMCO MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIMEX MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 16
TALLEY GROUP LTD.
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
No Information 316
No Known Device Problem 110
No code available 87
Device alarm system issue 19
Device operates differently than expected 12
Suction issue 11
Pressure issue 9
Leak 9
Burn of device or device component 8
Power source issue 8
Use of Device Issue 6
Electrical issue 6
Difficult to remove 5
Electronic property issue 5
Device displays error message 4
Smoking 4
Overheating of device or device component 4
Not audible alarm 4
Blockage within device or device component 3
Air leak 3
Device inoperable 3
Improper or incorrect procedure or method 3
Charging issue 3
Not Applicable 3
Device handling issue 2
Moisture or humidity problem 2
Pumping issue 2
Battery issue 2
Device contamination with blood or blood product 2
Device Issue 2
Low battery 2
Pumping stopped 2
Loss of power 2
Failure to power-up 2
Decrease in pressure 2
Failure to charge 2
Entrapment of device or device component 2
Fire 2
Fluid leak 2
Detachment of device component 2
Crack 1
Decrease in suction 1
Material discolored 1
Hole in material 1
Explode 1
Charred 1
Circuit Failure 1
Defective Alarm 1
Failure to pump 1
Loose or intermittent connection 1
Markings, none 1
Melted 1
Occlusion within device 1
Device emits odor 1
Power Conditioning Issue 1
Material rigid or stiff 1
Spark 1
Patient-device incompatibility 1
Electro-static discharge 1
Other (for use when an appropriate device code cannot be identified) 1
Blocked connection 1
Calibration issue 1
Detachment of device or device component 1
Foreign material present in device 1
Maintenance does not comply to manufacturers recommendations 1
Therapeutic or diagnostic output failure 1
Torn material 1
No Pressure 1
Noise, Audible 1
Total Device Problems 706

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 3 0 2 0 6 0 2 2
Class III 0 0 2 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Accuro Medical Product LLC II Oct-04-2012
2 ConvaTec III Sep-29-2009
3 ConvaTec III Sep-09-2009
4 Convatec Inc. II Sep-28-2010
5 KCI USA, INC. II May-30-2017
6 KCI USA, INC. II Jan-06-2016
7 KCI USA, INC. II Mar-05-2014
8 KCI USA, Inc. II Oct-15-2014
9 KCI USA, Inc. II Jan-25-2010
10 Smith & Nephew Inc. II Mar-10-2014
11 Smith & Nephew Inc. II Feb-21-2014
12 Smith & Nephew Inc. II Jan-26-2012
13 Smith & Nephew Inc. II Nov-03-2010
14 Smith & Nephew, Inc. II Jan-18-2017
15 Smith & Nephew, Inc. II Sep-20-2016
16 Smith & Nephew, Inc. II Oct-08-2014
17 Smith & Nephew, Inc. II Sep-23-2014

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