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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 13
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 5
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
PROXY BIOMEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
PROXY BIOMEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Insufficient Information 26312
Defective Device 25001
Adverse Event Without Identified Device or Use Problem 16089
Appropriate Term/Code Not Available 2735
Migration or Expulsion of Device 2573
Patient Device Interaction Problem 760
Loss of or Failure to Bond 497
Material Erosion 449
Material Split, Cut or Torn 363
Material Deformation 352
Material Integrity Problem 307
Detachment of Device or Device Component 221
Material Perforation 149
Degraded 131
Break 122
Material Separation 101
Torn Material 95
Migration 77
No Apparent Adverse Event 60
Use of Device Problem 60
Product Quality Problem 58
Hole In Material 51
Failure To Adhere Or Bond 48
Tear, Rip or Hole in Device Packaging 46
Extrusion 45
Folded 42
Material Protrusion/Extrusion 28
Other (for use when an appropriate device code cannot be identified) 28
Detachment Of Device Component 27
Unsealed Device Packaging 26
Material Frayed 23
Packaging Problem 23
Device Markings/Labelling Problem 21
Expiration Date Error 20
Contamination 18
Material Disintegration 18
Material Too Rigid or Stiff 13
Shelf Life Exceeded 13
Material Rupture 13
Device Expiration Issue 13
Deformation Due to Compressive Stress 13
Device Contamination with Chemical or Other Material 12
Peeled/Delaminated 11
Delamination 11
Human-Device Interface Problem 10
Entrapment of Device 10
Patient-Device Incompatibility 9
Incorrect, Inadequate or Imprecise Resultor Readings 9
Mechanics Altered 8
Improper or Incorrect Procedure or Method 8
Obstruction of Flow 7
Device Issue 7
Device Damaged by Another Device 7
Sticking 6
Device Operates Differently Than Expected 6
Material Puncture/Hole 6
Device Appears to Trigger Rejection 6
Loosening of Implant Not Related to Bone-Ingrowth 5
Device Dislodged or Dislocated 5
Off-Label Use 5
Difficult to Open or Close 5
Device Slipped 4
Material Fragmentation 4
Microbial Contamination of Device 4
Bent 3
Split 3
Kinked 3
Difficult or Delayed Positioning 3
Structural Problem 2
Incomplete or Missing Packaging 2
Explanted 2
Difficult To Position 2
Component Missing 2
Impedance Problem 2
Inflation Problem 2
Misassembled 2
Unexpected Therapeutic Results 2
Unraveled Material 2
Inadequacy of Device Shape and/or Size 2
Device Or Device Fragments Location Unknown 1
Therapeutic or Diagnostic Output Failure 1
Out-Of-Box Failure 1
Inadequate Service 1
Ring 1
Crack 1
Device Reprocessing Problem 1
Device Contaminated During Manufacture or Shipping 1
Cut In Material 1
Material Twisted/Bent 1
Malfunction 1
Wrinkled 1
Failure to Auto Stop 1
Missing Value Reason 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
Total Device Problems 77261

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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