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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device mesh, surgical, polymeric
Regulation Description Surgical mesh.
Product CodeFTL
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
AROA BIOSURGERY LIMITED (FORMERLY MESYNTHES LIMITED)
  SUBSTANTIALLY EQUIVALENT 1
AROA BIOSURGERY LTD.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
CR BARD
  SUBSTANTIALLY EQUIVALENT 1
CR BARD INC.
  SUBSTANTIALLY EQUIVALENT 1
DEEP BLUE MEDICAL ADVANCES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON INC
  SUBSTANTIALLY EQUIVALENT 1
ETHICON, INC
  SUBSTANTIALLY EQUIVALENT 1
ETHICON, INC.
  SUBSTANTIALLY EQUIVALENT 5
EXOGENESIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FEG TEXTILTECHNIK FORSCHUNGS- UND ENTWICKLUNGSGESELLSCHAFT
  SUBSTANTIALLY EQUIVALENT 1
FEG TEXTILTECHNIK FORSCHUNGS-UND ENTWICKLUNGSGESELLSCHAFT
  SUBSTANTIALLY EQUIVALENT 1
ICONLAB INC.
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL LIFE SCIENCES
  SUBSTANTIALLY EQUIVALENT 1
MAST BIOSURGERY
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
PROXY BIOMEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOFRADIM PRODUCTION
  SUBSTANTIALLY EQUIVALENT 4
SURGICAL INNOVATION ASSOCIATES, INC.
  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 9593 9593

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Device 34656 34656
Insufficient Information 32886 32886
Adverse Event Without Identified Device or Use Problem 24082 24082
Patient Device Interaction Problem 5235 5235
Appropriate Term/Code Not Available 3254 3254
Migration or Expulsion of Device 3207 3207
Patient-Device Incompatibility 949 949
Material Deformation 615 615
Material Erosion 526 526
Loss of or Failure to Bond 511 511
Material Split, Cut or Torn 491 491
Material Integrity Problem 408 408
Detachment of Device or Device Component 293 293
Degraded 185 185
Migration 164 164
No Apparent Adverse Event 153 153
Break 150 150
Material Perforation 150 150
Mechanics Altered 130 130
Material Separation 125 125
Device Operates Differently Than Expected 120 120
Torn Material 91 91
Material Protrusion/Extrusion 83 83
Use of Device Problem 79 79
Therapeutic or Diagnostic Output Failure 79 79
Product Quality Problem 69 69
Contamination 66 66
Microbial Contamination of Device 61 61
Extrusion 54 54
Hole In Material 48 48
Tear, Rip or Hole in Device Packaging 45 45
Failure To Adhere Or Bond 44 44
Detachment Of Device Component 37 37
Folded 36 36
Packaging Problem 32 32
Expiration Date Error 32 32
Improper or Incorrect Procedure or Method 31 31
Device Markings/Labelling Problem 30 30
Material Twisted/Bent 30 30
Material Disintegration 28 28
Material Frayed 26 26
Unsealed Device Packaging 25 25
Device Dislodged or Dislocated 24 24
Deformation Due to Compressive Stress 23 23
Entrapment of Device 23 23
Unexpected Therapeutic Results 21 21
Delivered as Unsterile Product 20 20
Device Contamination with Chemical or Other Material 20 20
Defective Component 18 18
Nonstandard Device 18 18
Structural Problem 17 17
Peeled/Delaminated 15 15
Shelf Life Exceeded 14 14
Device Expiration Issue 13 13
Loosening of Implant Not Related to Bone-Ingrowth 13 13
Loose or Intermittent Connection 13 13
Material Rupture 12 12
Physical Resistance/Sticking 12 12
Material Fragmentation 11 11
Material Puncture/Hole 11 11
Difficult to Remove 10 10
Delamination 10 10
Human-Device Interface Problem 10 10
Sticking 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
Malposition of Device 7 7
Device Slipped 7 7
Retraction Problem 6 6
Device Issue 6 6
Obstruction of Flow 6 6
Positioning Problem 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 33248 33260
Disability 17962 17962
Hernia 15518 15523
Adhesion(s) 13207 13216
Unspecified Infection 7821 7828
No Code Available 7311 7314
Insufficient Information 4135 4135
Inflammation 4131 4134
Abdominal Pain 3163 3166
Not Applicable 3017 3017
Obstruction/Occlusion 2789 2790
Abscess 2718 2720
Unspecified Tissue Injury 2356 2356
Seroma 2011 2015
Nausea 1874 1875
Scarring 1794 1796
Erosion 1789 1791
Discomfort 1711 1712
Fistula 1513 1517
Scar Tissue 1481 1481
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1476 1476
Impaired Healing 1300 1303
Purulent Discharge 1259 1259
Failure of Implant 1153 1154
No Information 922 923
Abdominal Distention 920 920
Discharge 912 912
Foreign Body Reaction 861 863
Hematoma 842 842
Necrosis 786 786
Swelling 710 711
Nerve Damage 704 707
Emotional Changes 659 660
No Consequences Or Impact To Patient 652 652
Blood Loss 636 636
Ascites 611 611
Fibrosis 607 607
Vomiting 579 580
Incontinence 530 530
Diarrhea 471 471
Fluid Discharge 439 439
Prolapse 412 412
Fever 403 403
Deformity/ Disfigurement 368 368
Chills 357 357
Bacterial Infection 355 355
Wound Dehiscence 347 347
Weight Changes 311 312
Cellulitis 298 298
Urinary Tract Infection 294 294
Granuloma 285 286
Hemorrhage/Bleeding 256 256
Erythema 253 253
Sepsis 245 247
Bowel Perforation 240 240
Post Operative Wound Infection 233 234
Urinary Retention 230 230
Constipation 224 224
Death 208 208
Perforation 206 206
Staphylococcus Aureus 200 200
Edema 192 193
No Known Impact Or Consequence To Patient 186 186
Reaction 184 186
Foreign Body In Patient 184 184
No Clinical Signs, Symptoms or Conditions 180 180
Burning Sensation 178 178
Urinary Frequency 175 175
Ischemia 170 170
Internal Organ Perforation 169 169
Decreased Appetite 169 169
Swelling/ Edema 161 161
Tissue Damage 160 163
Distress 143 143
Cyst(s) 135 135
Micturition Urgency 118 118
Hematuria 111 111
Rash 108 108
Depression 105 105
Complaint, Ill-Defined 98 98
Weakness 98 98
Ambulation Difficulties 95 96
Abnormal Vaginal Discharge 92 92
Dysuria 91 91
Fatigue 90 91
Numbness 88 88
Itching Sensation 78 78
Peritonitis 74 74
Cramp(s) 73 73
Anxiety 73 74
Ulcer 71 71
Strangulation 68 68
Hypersensitivity/Allergic reaction 68 69
Corneal Pannus 68 68
Low Blood Pressure/ Hypotension 65 66
Neuropathy 64 64
Patient Problem/Medical Problem 63 63
Anemia 62 63
Tachycardia 61 61

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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