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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
Regulation Description Surgical mesh.
Definition Surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility
Product CodeOTN
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
AMERICAN MEDICAL
  SUBSTANTIALLY EQUIVALENT 14
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 3
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 4
CALDERA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 6
CL MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST MANUFACTURING US LLC
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 5
GENERIC MEDICAL DEVICE, INC.
  SUBSTANTIALLY EQUIVALENT 2
HERNIAMESH S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
MENTOR CORP.
  SUBSTANTIALLY EQUIVALENT 4
MPATHY MEDICAL DEVICES, LTD.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Material erosion 2457
Migration of device or device component 1325
No Known Device Problem 1072
No Information 885
No code available 356
Extrusion 74
Other (for use when an appropriate device code cannot be identified) 54
Failure to separate 6
Break 5
Difficult to remove 4
Difficult to advance 4
Dislodged or dislocated 3
Bent 3
Material deformation 2
Material integrity issue 2
Tear, rip or hole in device packaging 2
Deployment issue 2
Device operates differently than expected 2
Detachment of device component 2
Explanted 2
Material fragmentation 1
Loose or intermittent connection 1
Difficult to deploy 1
Disconnection 1
Electro-magnetic interference (EMI) 1
Unknown (for use when the device problem is not known) 1
Material perforation 1
Incomplete or missing packaging 1
Difficult to position 1
Material puncture 1
Rejection 1
Device packaging compromised 1
Malposition of device 1
Split 1
Stretched 1
Electro-static discharge 1
Material Protrusion 1
Material twisted 1
Osseointegration issue 1
Total Device Problems 6281

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 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 American Medical Systems, Inc. II Dec-16-2014

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