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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
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 8
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 4
ETHICON
  SUBSTANTIALLY EQUIVALENT 7
ETHICON INC.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON, INC
  SUBSTANTIALLY EQUIVALENT 1
ETHICON, INC.
  SUBSTANTIALLY EQUIVALENT 5
INTERNATIONAL LIFE SCIENCES
  SUBSTANTIALLY EQUIVALENT 1
MAST BIOSURGERY USA INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 4
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

MDR Year MDR Reports MDR Events
2016 2392 2392
2017 3929 3929
2018 11871 11871
2019 21720 21720
2020 18816 18816
2021 5840 5840

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 32809 32809
Defective Device 32430 32430
Adverse Event Without Identified Device or Use Problem 22839 22839
Appropriate Term/Code Not Available 3233 3233
Migration or Expulsion of Device 3037 3037
Patient Device Interaction Problem 2905 2905
Patient-Device Incompatibility 837 837
Material Deformation 587 587
Material Erosion 519 519
Loss of or Failure to Bond 510 510
Material Split, Cut or Torn 469 469
Material Integrity Problem 384 384
Detachment of Device or Device Component 288 288
Degraded 171 171
No Apparent Adverse Event 153 153
Material Perforation 150 150
Migration 150 150
Break 147 147
Material Separation 121 121
Device Operates Differently Than Expected 120 120
Torn Material 91 91
Use of Device Problem 79 79
Therapeutic or Diagnostic Output Failure 78 78
Material Protrusion/Extrusion 77 77
Product Quality Problem 69 69
Contamination 66 66
Microbial Contamination of Device 61 61
Extrusion 54 54
Mechanics Altered 52 52
Hole In Material 48 48
Failure To Adhere Or Bond 44 44
Tear, Rip or Hole in Device Packaging 44 44
Detachment Of Device Component 37 37
Folded 36 36
Packaging Problem 32 32
Expiration Date Error 31 31
Improper or Incorrect Procedure or Method 31 31
Device Markings/Labelling Problem 29 29
Material Twisted/Bent 27 27
Material Disintegration 26 26
Material Frayed 26 26
Unsealed Device Packaging 25 25
Deformation Due to Compressive Stress 23 23
Entrapment of Device 23 23
Device Dislodged or Dislocated 22 22
Unexpected Therapeutic Results 21 21
Device Contamination with Chemical or Other Material 20 20
Defective Component 18 18
Nonstandard Device 18 18
Structural Problem 16 16
Peeled/Delaminated 15 15
Shelf Life Exceeded 14 14
Device Expiration Issue 13 13
Loosening of Implant Not Related to Bone-Ingrowth 13 13
Material Rupture 12 12
Delivered as Unsterile Product 12 12
Loose or Intermittent Connection 12 12
Physical Resistance/Sticking 12 12
Sticking 10 10
Human-Device Interface Problem 10 10
Material Fragmentation 10 10
Material Puncture/Hole 10 10
Difficult to Remove 10 10
Delamination 10 10
Failure to Osseointegrate 9 9
Device Damaged by Another Device 8 8
Incorrect, Inadequate or Imprecise Resultor Readings 8 8
Material Too Rigid or Stiff 8 8
Device Appears to Trigger Rejection 8 8
Unintended Movement 8 8
Contamination /Decontamination Problem 7 7
Device Slipped 7 7
Retraction Problem 6 6
Device Issue 6 6
Obstruction of Flow 6 6
Positioning Problem 6 6
Malposition of Device 6 6
Component Missing 5 5
Expulsion 5 5
Difficult to Open or Close 5 5
Protective Measures Problem 4 4
Off-Label Use 4 4
Inadequacy of Device Shape and/or Size 4 4
Biocompatibility 3 3
Unraveled Material 3 3
Kinked 3 3
Difficult or Delayed Positioning 3 3
Device-Device Incompatibility 3 3
Mechanical Problem 3 3
Device Emits Odor 3 3
Inflation Problem 3 3
Crack 3 3
Fracture 3 3
Bent 3 3
Material Invagination 2 2
Explanted 2 2
Difficult To Position 2 2
Device Packaging Compromised 2 2
Device Or Device Fragments Location Unknown 2 2
Wrinkled 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 42528 42528
Pain 31886 31898
Disability 17962 17962
Hernia 14829 14834
Adhesion(s) 12590 12599
Unspecified Infection 7529 7536
No Code Available 7311 7314
Inflammation 3953 3956
Abdominal Pain 3059 3062
Not Applicable 3017 3017
Obstruction/Occlusion 2648 2649
Abscess 2560 2562
Seroma 1914 1918
Insufficient Information 1850 1850
Nausea 1800 1801
Scarring 1794 1796
Erosion 1719 1721
Unspecified Tissue Injury 1691 1691
Discomfort 1557 1558
Fistula 1447 1451
Scar Tissue 1354 1354
Impaired Healing 1240 1243
Purulent Discharge 1216 1216
Failure of Implant 1088 1089
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1010 1010
No Information 922 923
Discharge 912 912
Abdominal Distention 886 886
Foreign Body Reaction 833 835
Hematoma 809 809
Necrosis 750 750
Swelling 710 711
Nerve Damage 675 678
No Consequences Or Impact To Patient 652 652
Blood Loss 636 636
Emotional Changes 625 626
Fibrosis 585 585
Ascites 575 575
Vomiting 563 564
Incontinence 526 526
Diarrhea 444 444
Prolapse 405 405
Fever 389 389
Deformity/ Disfigurement 364 364
Fluid Discharge 361 361
Chills 337 337
Bacterial Infection 333 333
Wound Dehiscence 327 327
Weight Changes 296 297
Cellulitis 289 289
Urinary Tract Infection 283 283
Granuloma 272 273
Erythema 250 250
Sepsis 239 241
Bowel Perforation 235 235
Hemorrhage/Bleeding 234 234
Urinary Retention 229 229
Post Operative Wound Infection 223 224
Constipation 218 218
Death 208 208
Staphylococcus Aureus 200 200
Perforation 199 199
Edema 192 193
No Known Impact Or Consequence To Patient 186 186
Reaction 184 186
Foreign Body In Patient 174 174
Urinary Frequency 173 173
Burning Sensation 172 172
Internal Organ Perforation 165 165
Ischemia 163 163
Tissue Damage 160 163
Decreased Appetite 141 141
Cyst(s) 127 127
Distress 126 126
Micturition Urgency 114 114
Hematuria 110 110
Rash 108 108
Swelling/ Edema 104 104
Complaint, Ill-Defined 98 98
Weakness 98 98
Depression 97 97
No Clinical Signs, Symptoms or Conditions 95 95
Ambulation Difficulties 92 93
Abnormal Vaginal Discharge 87 87
Fatigue 87 88
Dysuria 86 86
Numbness 85 85
Itching Sensation 77 77
Peritonitis 74 74
Cramp(s) 73 73
Anxiety 73 74
Strangulation 68 68
Ulcer 68 68
Low Blood Pressure/ Hypotension 65 66
Corneal Pannus 65 65
Hypersensitivity/Allergic reaction 63 64
Neuropathy 63 63
Patient Problem/Medical Problem 63 63
Tachycardia 60 60
Ulceration 59 59

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 Covidien Llc II Feb-22-2021
5 Ethicon, Inc. II Dec-03-2020
6 Novus Scientific Ab II Aug-19-2016
7 Sofradim Production II Apr-26-2018
8 TYRX Inc. II Aug-15-2016
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