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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tape and bandage, adhesive
Regulation Description Medical adhesive tape and adhesive bandage.
Product CodeKGX
Regulation Number 880.5240
Device Class 1


Premarket Reviews
ManufacturerDecision
3M COMPANY
  1
  SUBSTANTIALLY EQUIVALENT 5
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 4
BD
  SUBSTANTIALLY EQUIVALENT 1
BEIERSDORF
  2
  SUBSTANTIALLY EQUIVALENT 13
BYRON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST MANUFACTURING US LLC
  SUBSTANTIALLY EQUIVALENT 1
CONMED
  SUBSTANTIALLY EQUIVALENT 1
DALE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEROYAL
  SUBSTANTIALLY EQUIVALENT 3
DURDEN ENTERPRISES
  SUBSTANTIALLY EQUIVALENT 1
EMPI
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 1
GAINOR MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
GRAHAM-FIELD HEALTH PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INAMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 13
KENDALL
  SUBSTANTIALLY EQUIVALENT 2
MARINE POLYMER TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 4
SPENCO
  SUBSTANTIALLY EQUIVALENT - KIT 1

Device Problems
No Known Device Problem 181
Failure to Adhere or Bond 24
Dislodged 21
No Information 20
Failure to obtain samples 17
Loss of or failure to bond 12
No code available 6
Use of Device Issue 4
Unknown (for use when the device problem is not known) 4
Improper or incorrect procedure or method 4
Defective item 4
Sticking 3
Patient-device incompatibility 3
Delamination 3
Device operates differently than expected 2
Tear, rip or hole in device packaging 2
Inadequate user interface 2
Slippage of device or device component 2
Source, detachment from 1
Other (for use when an appropriate device code cannot be identified) 1
Bolus mechanism failure 1
Break 1
Temperature issue 1
Difficult to open or remove packaging material 1
Malfunction 1
Foreign material present in device 1
Leak 1
Loose 1
Needle, separation 1
Normal 1
Unsealed device packaging 1
Material separation 1
Device Issue 1
Device packaging compromised 1
Human-Device Interface Issue 1
Difficult to remove 1
Delivered as unsterile product 1
Locking mechanism failure 1
Chemical issue 1
Total Device Problems 335

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

Recalls
Manufacturer Recall Class Date Posted
1 3M Company / Medical Division II Apr-20-2010
2 ASO, LLC II Aug-25-2015
3 Breg Inc, An Orthofix Company II Sep-06-2012
4 Deroyal Industries, Inc. Lafollette III Apr-17-2012
5 Ethicon, Inc. II Mar-02-2011
6 Jiangsu Wujin Hualian Health Dressing Co., Ltd. II May-13-2011
7 Owens & Minor Distribution, Inc. II Jan-30-2016
8 Pharmaplast S.A.E. II Apr-01-2011
9 Zipline Medical II Mar-02-2015

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