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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 10738
Defective Device 10216
Adverse Event Without Identified Device or Use Problem 8902
Appropriate Term/Code Not Available 2751
Migration or Expulsion of Device 1210
Material Erosion 240
Material Deformation 223
Detachment of Device or device Component 187
Loss of or Failure to Bond 181
Material Integrity Problem 122
Break 116
Material Split, Cut or Torn 112
Torn Material 95
Material Separation 90
Patient Device Interaction Problem 60
Material Perforation 59
No Apparent Adverse Event 57
Use of Device Problem 53
Migration 52
Hole In Material 51
Failure To Adhere Or Bond 49
Extrusion 48
Other (for use when an appropriate device code cannot be identified) 45
Folded 42
Tear, Rip or Hole in Device Packaging 41
Degraded 38
Detachment Of Device Component 27
Material Protrusion / Extrusion 26
Unsealed Device Packaging 22
Device Markings / Labelling Problem 21
Material Frayed 18
Material Disintegration 16
Product Quality Problem 13
Deformation Due to Compressive Stress 13
Material Rupture 13
Device Expiration Issue 13
Shelf Life Exceeded 13
Material Too Rigid or Stiff 13
Contamination During Use 12
Expiration Date Error 11
Device Operates Differently Than Expected 11
Delamination 11
Packaging Problem 11
Incorrect, Inadequate or Imprecise Result or Readings 8
Device Issue 8
Peeled / Delaminated 8
Device Contamination with Chemical or Other Material 8
Human-Device Interface Problem 7
Patient-Device Incompatibility 6
Sticking 6
Device Damaged by Another Device 6
Device Dislodged or Dislocated 5
Explanted 5
Off-Label Use 4
Device Slipped 4
Microbial Contamination of Device 4
Split 3
Kinked 3
Mechanics Altered 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
Entrapment of Device 2
Impedance Problem 2
Difficult To Position 2
Crack 2
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
Manufacturing, Packaging or Shipping Problem 1
Material Distortion 1
Reaction 1
Flaked 1
Malfunction 1
Malposition of device 1
Biocompatibility 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 36192

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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