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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 12
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 6
ETHICON
  SUBSTANTIALLY EQUIVALENT 6
ETHICON INC.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON, INC
  SUBSTANTIALLY EQUIVALENT 1
ETHICON, INC.
  SUBSTANTIALLY EQUIVALENT 4
INTERNATIONAL LIFE SCIENCES
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 4
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 3
PROXY BIOMEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
PROXY BIOMEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Insufficient Information 21090
Defective Device 19907
Adverse Event Without Identified Device or Use Problem 13737
Appropriate Term/Code Not Available 2735
Migration or Expulsion of Device 2247
Patient Device Interaction Problem 543
Loss of or Failure to Bond 492
Material Erosion 447
Material Split, Cut or Torn 316
Material Deformation 305
Material Integrity Problem 278
Detachment of Device or device Component 213
Material Perforation 149
Break 119
Degraded 107
Material Separation 95
Torn Material 95
Migration 70
No Apparent Adverse Event 59
Use of Device Problem 58
Product Quality Problem 57
Hole In Material 51
Failure To Adhere Or Bond 48
Tear, Rip or Hole in Device Packaging 45
Extrusion 45
Folded 42
Other (for use when an appropriate device code cannot be identified) 28
Material Protrusion / Extrusion 27
Detachment Of Device Component 27
Unsealed Device Packaging 25
Material Frayed 23
Device Markings / Labelling Problem 21
Packaging Problem 19
Material Disintegration 16
Expiration Date Error 16
Material Too Rigid or Stiff 13
Shelf Life Exceeded 13
Material Rupture 13
Device Expiration Issue 13
Deformation Due to Compressive Stress 13
Contamination During Use 12
Delamination 11
Device Contamination with Chemical or Other Material 11
Peeled / Delaminated 10
Incorrect, Inadequate or Imprecise Result or Readings 9
Human-Device Interface Problem 9
Entrapment of Device 9
Device Issue 7
Device Damaged by Another Device 7
Sticking 6
Device Operates Differently Than Expected 6
Mechanics Altered 6
Improper or Incorrect Procedure or Method 6
Patient-Device Incompatibility 6
Material Puncture / Hole 5
Device Dislodged or Dislocated 5
Microbial Contamination of Device 4
Off-Label Use 4
Device Slipped 4
Difficult to Open or Close 3
Material Fragmentation 3
Kinked 3
Bent 3
Split 3
Unexpected Therapeutic Results 2
Impedance Problem 2
Inflation Problem 2
Misassembled 2
Inadequacy of Device Shape and/or Size 2
Obstruction of Flow 2
Difficult or Delayed Positioning 2
Structural Problem 2
Explanted 2
Difficult To Position 2
Component Missing 2
Incomplete or Missing Packaging 2
Implant extrusion 1
Overheating of Device 1
Shipping Damage or Problem 1
Material Discolored 1
Flaked 1
Activation, Positioning or Separation Problem 1
Inadequate User Interface 1
Handpiece 1
Incorrect Or Inadequate Test Results 1
Malposition of device 1
Biocompatibility 1
Device Packaging Compromised 1
Incorrect Device Or Component Shipped 1
Material Distortion 1
Device Difficult to Maintain 1
Manufacturing, Packaging or Shipping Problem 1
Difficult to Insert 1
Low Readings 1
Physical Resistance / Sticking 1
Device Or Device Fragments Location Unknown 1
Therapeutic or Diagnostic Output Failure 1
Out-Of-Box Failure 1
Inadequate Service 1
Ring 1
Total Device Problems 63817

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 EXP Pharmaceutical Services Corp II Jul-24-2015
5 MAST Biosurgery USA, Inc II Feb-10-2015
6 Novus Scientific Ab II Aug-19-2016
7 Sofradim Production II Apr-26-2018
8 Stryker Craniomaxillofacial Division II Feb-11-2015
9 TYRX Inc. II Aug-15-2016

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