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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 3
GENADYNE BIOTECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 6
INNOVATIVE THERAPIES, INC.
  SUBSTANTIALLY EQUIVALENT 4
KINETIC CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 22
MEDELA
  SUBSTANTIALLY EQUIVALENT 5
MOLNLYCKE HEALTH CARE
  SUBSTANTIALLY EQUIVALENT 1
PREMCO MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIMEX MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 13
TALLEY GROUP LTD.
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
No Information 254
No Known Device Problem 62
No code available 21
Device alarm system issue 18
Device operates differently than expected 8
Suction issue 7
Leak 7
Burn of device or device component 6
Use of Device Issue 6
Difficult to remove 5
Power source issue 5
Device displays error message 4
Not audible alarm 4
Device inoperable 3
Improper or incorrect procedure or method 3
Not Applicable 3
Moisture or humidity problem 2
Device handling issue 2
Air leak 2
Device contamination with blood or blood product 2
Blockage within device or device component 2
Detachment of device component 2
Entrapment of device or device component 2
Fluid leak 2
Loss of power 2
Failure to power-up 1
Hole in material 1
Loose or intermittent connection 1
Markings, none 1
Device emits odor 1
Explode 1
Fire 1
Crack 1
Material discolored 1
Failure to charge 1
Charred 1
Device Issue 1
Electronic property issue 1
Foreign material present in device 1
Spark 1
Patient-device incompatibility 1
Charging issue 1
Detachment of device or device component 1
Material rigid or stiff 1
Smoking 1
Electro-static discharge 1
Other (for use when an appropriate device code cannot be identified) 1
Noise, Audible 1
No Pressure 1
Pressure issue 1
Pumping issue 1
Therapeutic or diagnostic output failure 1
Torn material 1
Total Device Problems 462

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 3 0 2 0 6 0 1
Class III 0 0 2 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 Oct-08-2014
14 Smith & Nephew, Inc. II Sep-23-2014

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