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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 8
ETHICON INC.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON, INC
  SUBSTANTIALLY EQUIVALENT 1
ETHICON, INC.
  SUBSTANTIALLY EQUIVALENT 6
INTERNATIONAL LIFE SCIENCES
  SUBSTANTIALLY EQUIVALENT 1
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 17070
Defective Device 15982
Adverse Event Without Identified Device or Use Problem 12283
Appropriate Term/Code Not Available 2759
Migration or Expulsion of Device 1774
Loss of or Failure to Bond 447
Material Erosion 439
Material Deformation 241
Material Integrity Problem 216
Material Split, Cut or Torn 212
Detachment of Device or device Component 203
Material Perforation 138
Break 121
Torn Material 95
Material Separation 91
Patient Device Interaction Problem 90
Migration 64
Degraded 60
No Apparent Adverse Event 59
Use of Device Problem 57
Hole In Material 51
Failure To Adhere Or Bond 49
Extrusion 48
Other (for use when an appropriate device code cannot be identified) 45
Tear, Rip or Hole in Device Packaging 43
Folded 42
Product Quality Problem 40
Material Protrusion / Extrusion 28
Detachment Of Device Component 27
Unsealed Device Packaging 24
Material Frayed 24
Device Markings / Labelling Problem 22
Material Disintegration 16
Expiration Date Error 15
Packaging Problem 14
Material Rupture 13
Device Expiration Issue 13
Deformation Due to Compressive Stress 13
Material Too Rigid or Stiff 13
Shelf Life Exceeded 13
Contamination During Use 12
Human-Device Interface Problem 11
Delamination 11
Device Operates Differently Than Expected 11
Device Contamination with Chemical or Other Material 11
Peeled / Delaminated 10
Incorrect, Inadequate or Imprecise Result or Readings 9
Device Issue 8
Entrapment of Device 8
Device Damaged by Another Device 7
Sticking 6
Patient-Device Incompatibility 6
Explanted 5
Mechanics Altered 5
Material Puncture / Hole 5
Device Dislodged or Dislocated 5
Microbial Contamination of Device 4
Device Slipped 4
Off-Label Use 4
Material Fragmentation 3
Kinked 3
Difficult to Open or Close 3
Bent 3
Split 3
Unexpected Therapeutic Results 2
Impedance Problem 2
Inflation Problem 2
Misassembled 2
Crack 2
Inadequacy of Device Shape and/or Size 2
Difficult To Position 2
Device Packaging Compromised 2
Improper or Incorrect Procedure or Method 2
Device Difficult to Setup or Prepare 2
Incomplete or Missing Packaging 2
Obstruction of Flow 2
Structural Problem 2
Manufacturing, Packaging or Shipping Problem 1
Physical Resistance / Sticking 1
Low Readings 1
Difficult or Delayed Positioning 1
Activation, Positioning or Separation Problem 1
Inadequate User Interface 1
Handpiece 1
Reaction 1
Shipping Damage or Problem 1
Implant extrusion 1
Overheating of Device 1
Material Discolored 1
Flaked 1
Device Difficult to Maintain 1
Component Missing 1
Incorrect Or Inadequate Test Results 1
Malposition of device 1
Biocompatibility 1
Incorrect Device Or Component Shipped 1
Material Distortion 1
Device Or Device Fragments Location Unknown 1
Therapeutic or Diagnostic Output Failure 1
Ring 1
Total Device Problems 53160

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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