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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 12741
Defective Device 12141
Adverse Event Without Identified Device or Use Problem 10515
Appropriate Term/Code Not Available 2756
Migration or Expulsion of Device 1307
Material Erosion 277
Loss of or Failure to Bond 250
Material Deformation 234
Detachment of Device or device Component 198
Material Integrity Problem 149
Material Split, Cut or Torn 144
Break 118
Torn Material 95
Material Separation 91
Patient Device Interaction Problem 75
Material Perforation 68
No Apparent Adverse Event 57
Use of Device Problem 55
Migration 54
Hole In Material 51
Failure To Adhere Or Bond 49
Extrusion 48
Other (for use when an appropriate device code cannot be identified) 45
Degraded 44
Tear, Rip or Hole in Device Packaging 42
Folded 42
Material Protrusion / Extrusion 28
Detachment Of Device Component 27
Unsealed Device Packaging 23
Device Markings / Labelling Problem 22
Product Quality Problem 21
Material Frayed 20
Material Disintegration 16
Deformation Due to Compressive Stress 13
Material Rupture 13
Device Expiration Issue 13
Shelf Life Exceeded 13
Material Too Rigid or Stiff 13
Packaging Problem 12
Expiration Date Error 12
Contamination During Use 12
Device Operates Differently Than Expected 11
Delamination 11
Peeled / Delaminated 10
Device Contamination with Chemical or Other Material 10
Device Issue 8
Incorrect, Inadequate or Imprecise Result or Readings 8
Human-Device Interface Problem 7
Patient-Device Incompatibility 6
Device Damaged by Another Device 6
Sticking 6
Device Dislodged or Dislocated 5
Explanted 5
Off-Label Use 4
Device Slipped 4
Microbial Contamination of Device 4
Mechanics Altered 4
Entrapment of Device 3
Kinked 3
Split 3
Material Fragmentation 3
Difficult to Open or Close 3
Bent 3
Inflation Problem 2
Unexpected Therapeutic Results 2
Improper or Incorrect Procedure or Method 2
Device Difficult to Setup or Prepare 2
Material Puncture / Hole 2
Obstruction of Flow 2
Structural Problem 2
Misassembled 2
Incomplete or Missing Packaging 2
Device Packaging Compromised 2
Inadequacy of Device Shape and/or Size 2
Difficult To Position 2
Crack 2
Impedance Problem 2
Manufacturing, Packaging or Shipping Problem 1
Material Distortion 1
Reaction 1
Flaked 1
Malfunction 1
Malposition of device 1
Biocompatibility 1
Overheating of Device 1
Implant extrusion 1
Device Or Device Fragments Location Unknown 1
Cut In Material 1
Incorrect Or Inadequate Test Results 1
Inadequate User Interface 1
Missing Value Reason 1
Incorrect Device Or Component Shipped 1
Device Contaminated during manufacture or shipping 1
Physical Resistance / Sticking 1
Out-Of-Box Failure 1
Ring 1
Inadequate Service 1
Unraveled Material 1
Difficult or Delayed Positioning 1
Device Difficult to Maintain 1
Total Device Problems 42082

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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