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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pack, hot or cold, disposable
Regulation Description Hot or cold disposable pack.
Product CodeIMD
Regulation Number 890.5710
Device Class 1


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  1
  SUBSTANTIALLY EQUIVALENT 1
BIO-LIPID, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
CANDELA CORP.
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 3
DEROYAL
  SUBSTANTIALLY EQUIVALENT 1
GAYMAR INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 3
OMNI
  1
  SUBSTANTIALLY EQUIVALENT 3
PRISM
  1
  SUBSTANTIALLY EQUIVALENT 3
SPENCO
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 29
No Information 27
Improper or incorrect procedure or method 14
Device operates differently than expected 14
Other (for use when an appropriate device code cannot be identified) 9
Product quality issue 8
Nonstandard device or device component 6
No code available 6
Temperature issue 4
Use of Device Issue 3
Patient-device incompatibility 3
Unknown (for use when the device problem is not known) 2
Leak 2
Unexpected therapeutic results 2
Burst 2
Fluid leak 2
Heat 1
Heat, failure to 1
Insufficient heating 1
Charred 1
Break 1
Burn of device or device component 1
Difficult to remove 1
Material rupture 1
Occlusion within device 1
Overheating of device or device component 1
Premature system activation 1
Defective item 1
Dislodged or dislocated 1
Human-Device Interface Issue 1
Inadequate user interface 1
Total Device Problems 148

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

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Company II Sep-26-2008
2 Chattem Inc II Mar-08-2008
3 CooperSurgical, Inc. II Apr-07-2015
4 CooperSurgical, Inc. II Mar-19-2015
5 Pfizer Global II Dec-16-2010
6 Philips Electronics North America Corporation II Apr-04-2016
7 Philips Electronics North America Corporation II Dec-24-2015

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