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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device mesh, surgical, polymeric
Regulation Description Surgical mesh.
Product CodeFTL
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
ATRIUM MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
ATRIUM MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD INC.
  SUBSTANTIALLY EQUIVALENT 3
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 15
COUSIN BIOTECH S.A.S.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 9
ETHICON
  SUBSTANTIALLY EQUIVALENT 7
ETHICON INC.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON, INC
  SUBSTANTIALLY EQUIVALENT 1
ETHICON, INC.
  SUBSTANTIALLY EQUIVALENT 5
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
PROXY BIOMEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
PROXY BIOMEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHASOME
  SUBSTANTIALLY EQUIVALENT 1
SYNTHASOME, INC.
  SUBSTANTIALLY EQUIVALENT 1
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Insufficient Information 7314
Defective Device 6974
Adverse Event Without Identified Device or Use Problem 6768
Appropriate Term/Code Not Available 2749
Migration or Expulsion of Device 1006
Material Deformation 219
Detachment of Device or device Component 174
Material Erosion 162
Break 114
Torn Material 95
Material Separation 86
Material Integrity Problem 68
Material Split, Cut or Torn 62
No Apparent Adverse Event 57
Loss of or Failure to Bond 53
Hole In Material 51
Failure To Adhere Or Bond 49
Extrusion 48
Migration 45
Other (for use when an appropriate device code cannot be identified) 45
Use of Device Problem 43
Folded 42
Tear, Rip or Hole in Device Packaging 40
Patient Device Interaction Problem 34
Material Perforation 31
Detachment Of Device Component 27
Material Protrusion / Extrusion 25
Degraded 25
Device Markings / Labelling Problem 21
Unsealed Device Packaging 19
Material Frayed 17
Material Disintegration 16
Product Quality Problem 13
Deformation Due to Compressive Stress 13
Material Too Rigid or Stiff 13
Material Rupture 13
Device Expiration Issue 13
Shelf Life Exceeded 13
Contamination During Use 12
Expiration Date Error 11
Device Operates Differently Than Expected 11
Delamination 11
Packaging Problem 9
Incorrect, Inadequate or Imprecise Result or Readings 8
Device Issue 8
Device Contamination with Chemical or Other Material 7
Sticking 6
Human-Device Interface Problem 6
Patient-Device Incompatibility 6
Device Dislodged or Dislocated 5
Explanted 5
Device Damaged by Another Device 5
Off-Label Use 4
Device Slipped 4
Microbial Contamination of Device 4
Split 3
Kinked 3
Mechanics Altered 3
Material Fragmentation 3
Peeled / Delaminated 3
Bent 3
Inflation Problem 2
Unexpected Therapeutic Results 2
Device Difficult to Setup or Prepare 2
Material Puncture / Hole 2
Obstruction of Flow 2
Structural Problem 2
Misassembled 2
Inadequacy of Device Shape and/or Size 2
Incomplete or Missing Packaging 2
Device Packaging Compromised 2
Entrapment of Device 2
Impedance Problem 2
Difficult To Position 2
Crack 2
Overheating of Device 1
Implant extrusion 1
Cut In Material 1
Incorrect Or Inadequate Test Results 1
Inadequate User Interface 1
Device Or Device Fragments Location Unknown 1
Missing Value Reason 1
Manufacturing, Packaging or Shipping Problem 1
Material Distortion 1
Reaction 1
Flaked 1
Malfunction 1
Malposition of device 1
Biocompatibility 1
Out-Of-Box Failure 1
Ring 1
Incorrect Device Or Component Shipped 1
Device Contaminated during manufacture or shipping 1
Physical Resistance / Sticking 1
Inadequate Service 1
Unraveled Material 1
Difficult or Delayed Positioning 1
Component Missing 1
Shipping Damage or Problem 1
Failure to Auto Stop 1
Total Device Problems 26750

Recalls
Manufacturer Recall Class Date Posted
1 Atrium Medical Corporation II Feb-23-2018
2 Covidien LLC II Nov-14-2018
3 Covidien LLC II Jul-12-2018
4 Davol, Inc., Subs. C. R. Bard, Inc. II Nov-07-2014
5 Davol, Inc., Subs. C. R. Bard, Inc. II Jan-23-2014
6 EXP Pharmaceutical Services Corp II Jul-24-2015
7 MAST Biosurgery USA, Inc II Feb-10-2015
8 Novus Scientific Ab II Aug-19-2016
9 Sofradim Production II Apr-26-2018
10 Stryker Craniomaxillofacial Division II Feb-11-2015
11 TYRX Inc. II Aug-15-2016

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