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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 4
GENADYNE BIOTECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 6
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 298
No Known Device Problem 82
No code available 47
Device alarm system issue 18
Suction issue 11
Device operates differently than expected 8
Leak 7
Burn of device or device component 6
Use of Device Issue 6
Pressure issue 6
Power source issue 5
Difficult to remove 5
Device displays error message 4
Not audible alarm 4
Blockage within device or device component 3
Improper or incorrect procedure or method 3
Air leak 3
Device inoperable 3
Not Applicable 3
Moisture or humidity problem 2
Charging issue 2
Pumping issue 2
Device handling issue 2
Loss of power 2
Device contamination with blood or blood product 2
Detachment of device component 2
Entrapment of device or device component 2
Fluid leak 2
Hole in material 1
Explode 1
Fire 1
Loose or intermittent connection 1
Markings, none 1
Occlusion within device 1
Device emits odor 1
Overheating of device or device component 1
Crack 1
Decrease in suction 1
Material discolored 1
Failure to charge 1
Charred 1
Device Issue 1
Other (for use when an appropriate device code cannot be identified) 1
Spark 1
Patient-device incompatibility 1
Battery issue 1
Blocked connection 1
Failure to power-up 1
Material rigid or stiff 1
Smoking 1
Electro-static discharge 1
Noise, Audible 1
Therapeutic or diagnostic output failure 1
Torn material 1
Detachment of device or device component 1
Electronic property issue 1
Foreign material present in device 1
No Pressure 1
Total Device Problems 570

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 1
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 Jan-06-2016
6 KCI USA, INC. II Mar-05-2014
7 KCI USA, Inc. II Oct-15-2014
8 KCI USA, Inc. II Jan-25-2010
9 Smith & Nephew Inc. II Mar-10-2014
10 Smith & Nephew Inc. II Feb-21-2014
11 Smith & Nephew Inc. II Jan-26-2012
12 Smith & Nephew Inc. II Nov-03-2010
13 Smith & Nephew, Inc. II Jan-18-2017
14 Smith & Nephew, Inc. II Sep-20-2016
15 Smith & Nephew, Inc. II Oct-08-2014
16 Smith & Nephew, Inc. II Sep-23-2014

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