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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device sleeve, limb, compressible
Product CodeJOW
Regulation Number 870.5800
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
AIRCAST, INC.
  SUBSTANTIALLY EQUIVALENT 7
ALLIANCE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 6
ASCENT HEALTHCARE SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
AUGUSTINE MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIO COMPRESSION SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 7
C-BOOT LTD.
  SUBSTANTIALLY EQUIVALENT 2
CHATTANOOGA GROUP
  SUBSTANTIALLY EQUIVALENT 2
COMPRESSION TECHNOLOGIES UNLIMITED, INC.
  SUBSTANTIALLY EQUIVALENT 1
COMPRESSION THERAPY CONCEPTS
  SUBSTANTIALLY EQUIVALENT 3
CONVATEC LIMITED
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 7
CURRIE MEDICAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 4
DIDECO
  SUBSTANTIALLY EQUIVALENT 1
DJ ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 3
DOCTORS ORDERS
  SUBSTANTIALLY EQUIVALENT 1
GAYMAR INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
HUNTLEIGH HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 5
HYGIA HEALTH SERVICES, INC.
  SUBSTANTIALLY EQUIVALENT 9
KENDALL
  SUBSTANTIALLY EQUIVALENT 7
KINETIC CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 5
MEDASONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL COMPRESSION SYSTEMS (DBN) LTD.
  SUBSTANTIALLY EQUIVALENT 5
MEGO AFEK
  SUBSTANTIALLY EQUIVALENT 4
MICROTEK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
RENU MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
SENTECH MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
STERILMED
  SUBSTANTIALLY EQUIVALENT 2
TACTILE SYSTEMS TECHNOLOGY INC
  SUBSTANTIALLY EQUIVALENT 4
TYCO HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 3
UNIVERSITY OF UTAH HOSPITALS AND CLINICS
  SUBSTANTIALLY EQUIVALENT 2
VANGUARD MEDICAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
No Known Device Problem 91
Grounding malfunction 76
Unknown (for use when the device problem is not known) 68
Burn of device or device component 44
Break 35
Electrical issue 27
Use of Device Issue 22
Improper flow or infusion 22
Scratched material 18
Spark 18
Infusion or flow issue 15
Other (for use when an appropriate device code cannot be identified) 14
No Information 10
No code available 10
Smoking 10
Arcing 8
Cut in material 7
Fire 7
Leak 7
Improper or incorrect procedure or method 6
Power source issue 6
Device operates differently than expected 5
Device displays error message 5
Size incorrect for patient 4
Melted 4
Device or device component damaged by another device 3
Electromagnetic compatibility issue 3
Pumping issue 2
Electrical shorting 2
Device alarm system issue 2
Charred 2
User used incorrect product for intended use 2
Inflation issue 2
Device damaged prior to use 2
Inaccurate delivery 1
Split 1
High sensing threshold 1
Capturing issue 1
Detachment of device or device component 1
Kinked 1
Electro-static discharge 1
Device stops intermittently 1
Component falling 1
Degraded 1
Disconnection 1
No display or display failure 1
Drift 1
Failure to run on AC/DC 1
Air leak 1
Misapplication 1
Difficult to position 1
Failure to power-up 1
Fracture 1
Material frayed 1
Device unsafe to use in environment 1
Material Distortion 1
Material integrity issue 1
Torn material 1
Pressure issue 1
Output issue 1
Device handling issue 1
Total Device Problems 586

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 1 1 1 1 2 3 0 0 0 1
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Albahealth LLC II Nov-14-2011
2 Arjo, Inc. dba ArjoHuntleigh II Jun-26-2017
3 Arjo, Inc. dba ArjoHuntleigh II Dec-27-2012
4 Ascent Healthcare Solutions, Inc. II Sep-19-2008
5 Covidien LP II Oct-01-2010
6 DJO, LLC II Jul-03-2013
7 Medical Compression Systems II Jan-11-2012
8 Sterilmed Inc II Jan-13-2009
9 Stryker Sustainability Solutions II Feb-20-2013
10 Surgical Instrument Service And Savings, Inc. II Jul-01-2013

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