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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 7
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 2614
No code available 1808
Migration of device or device component 1587
No Known Device Problem 1242
No Information 916
Extrusion 88
Other (for use when an appropriate device code cannot be identified) 65
Break 8
Difficult to advance 6
Failure to separate 6
Material deformation 5
Detachment of device component 5
Torn material 4
Bent 4
Difficult to remove 4
Tear, rip or hole in device packaging 4
Device operates differently than expected 3
Dislodged or dislocated 3
Deployment issue 2
Explanted 2
Material integrity issue 2
Malposition of device 2
Material fragmentation 2
Hole in material 1
Incomplete or missing packaging 1
Device packaging compromised 1
Material Protrusion 1
Electro-magnetic interference (EMI) 1
Unsealed device packaging 1
Material separation 1
Loose or intermittent connection 1
Disconnection 1
Material perforation 1
Split 1
Difficult to position 1
Stretched 1
Rejection 1
Electro-static discharge 1
Osseointegration issue 1
Material twisted 1
Material puncture 1
Degraded 1
Unknown (for use when the device problem is not known) 1
Difficult to deploy 1
Total Device Problems 8403

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 1 0 0 0
Class III 0 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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