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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device sizer, mammary, breast implant volume
Product CodeMRD
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
MENTOR CORP.
  SUBSTANTIALLY EQUIVALENT 2
SPECIALTY SURGICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Foreign material present in device 8
Break 6
Material rupture 5
Malposition of device 1
Deflation, cause unknown 1
Device expiration issue 1
Unsealed device packaging 1
User used incorrect product for intended use 1
No Known Device Problem 1
Material puncture 1
Total Device Problems 26

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

Recalls
Manufacturer Recall Class Date Posted
1 Allergan Inc II Jul-07-2015
2 Mentor Texas, LP. II Jan-13-2015
3 Mentor Texas, LP. II Sep-04-2014

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