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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tampon, menstrual, unscented
Regulation Description Unscented menstrual tampon.
Product CodeHEB
Regulation Number 884.5470
Device Class 2


Premarket Reviews
ManufacturerDecision
COTTONS PTY, LTD
  SUBSTANTIALLY EQUIVALENT 1
FIRST QUALITY HYGIENIC, INC.
  SUBSTANTIALLY EQUIVALENT 7
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
KIMBERLY-CLARK CORP.
  SUBSTANTIALLY EQUIVALENT 14
MCNEIL-PPC, INC.
  SUBSTANTIALLY EQUIVALENT 1
PERSONAL PRODUCTS CO.
  SUBSTANTIALLY EQUIVALENT 14
PLAYTEX PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 10
PROCTER & GAMBLE CO.
  SUBSTANTIALLY EQUIVALENT 7
ROSTAM LTD.
  SUBSTANTIALLY EQUIVALENT 7
TAMBRANDS MANUFACTURING, INC.
  SUBSTANTIALLY EQUIVALENT 34
TOSAMA D.D.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Detachment of device component 6
Material fragmentation 5
Difficult to remove 2
No Known Device Problem 2
Not Applicable 1
Material separation 1
Sticking 1
Patient-device incompatibility 1
Failure to unwrap 1
Material Protrusion 1
Product quality issue 1
Entrapment of device or device component 1
Total Device Problems 23

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 0 1 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 First Quality Hygienic Inc II Sep-22-2010
2 Kimberly-Clark Corporation II Jan-11-2012

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