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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 7
ETHICON INC.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON, INC
  SUBSTANTIALLY EQUIVALENT 1
ETHICON, INC.
  SUBSTANTIALLY EQUIVALENT 5
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

MDR Year MDR Reports MDR Events
2015 2490 2490
2016 2387 2387
2017 3927 3927
2018 11864 11864
2019 21720 21720
2020 14392 14392

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 29471 29471
Defective Device 26871 26871
Adverse Event Without Identified Device or Use Problem 19216 19216
Appropriate Term/Code Not Available 3258 3258
Migration or Expulsion of Device 2917 2917
Patient Device Interaction Problem 832 832
Patient-Device Incompatibility 752 752
Material Erosion 679 679
Material Deformation 547 547
Loss of or Failure to Bond 507 507
Other (for use when an appropriate device code cannot be identified) 482 482
Material Split, Cut or Torn 384 384
Material Integrity Problem 347 347
Detachment of Device or Device Component 264 264
Device Operates Differently Than Expected 197 197
Break 174 174
Material Perforation 150 150
Degraded 145 145
Migration 128 128
Material Separation 124 124
Torn Material 110 110
Extrusion 86 86
Material Protrusion/Extrusion 82 82
No Apparent Adverse Event 76 76
Use of Device Problem 72 72
Therapeutic or Diagnostic Output Failure 67 67
Contamination 61 61
Product Quality Problem 61 61
Hole In Material 57 57
Failure To Adhere Or Bond 54 54
Microbial Contamination of Device 52 52
Folded 51 51
Tear, Rip or Hole in Device Packaging 50 50
Detachment Of Device Component 46 46
Entrapment of Device 40 40
Material Disintegration 32 32
Device Dislodged or Dislocated 31 31
Unsealed Device Packaging 29 29
Nonstandard Device 28 28
Improper or Incorrect Procedure or Method 28 28
Material Frayed 27 27
Packaging Problem 27 27
Device Markings/Labelling Problem 25 25
Material Twisted/Bent 24 24
Deformation Due to Compressive Stress 24 24
Mechanics Altered 23 23
Expiration Date Error 21 21
Unexpected Therapeutic Results 20 20
Defective Component 19 19
Structural Problem 18 18
Material Too Rigid or Stiff 17 17
Material Rupture 17 17
Peeled/Delaminated 16 16
Device Contamination with Chemical or Other Material 16 16
Shelf Life Exceeded 15 15
Device Expiration Issue 15 15
Loose or Intermittent Connection 13 13
Sticking 13 13
Material Fragmentation 12 12
Difficult to Remove 12 12
Delamination 11 11
Material Puncture/Hole 11 11
Physical Resistance/Sticking 11 11
Human-Device Interface Problem 10 10
Ring 9 9
Incorrect, Inadequate or Imprecise Resultor Readings 9 9
Malposition of Device 9 9
Unintended Movement 9 9
Device Appears to Trigger Rejection 8 8
Obstruction of Flow 8 8
Loosening of Implant Not Related to Bone-Ingrowth 8 8
Device Issue 7 7
Device Damaged by Another Device 7 7
Retraction Problem 7 7
Tears, rips, holes in device, device material 7 7
Inadequacy of Device Shape and/or Size 7 7
Positioning Problem 6 6
Contamination /Decontamination Problem 6 6
Device Slipped 6 6
Component Missing 6 6
Device Or Device Fragments Location Unknown 6 6
Off-Label Use 6 6
Difficult to Open or Close 6 6
Suture Thread 6 6
Bent 5 5
Device Packaging Compromised 5 5
Leak/Splash 5 5
Kinked 4 4
Unraveled Material 4 4
Scratched Material 4 4
Split 4 4
Failure to Osseointegrate 4 4
Crack 4 4
Inflation Problem 4 4
Device Emits Odor 4 4
Protective Measures Problem 4 4
Expulsion 4 4
Fracture 3 3
Mechanical Problem 3 3
Difficult To Position 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 38577 38577
Pain 28189 28193
Disability 16429 16429
Hernia 12719 12723
Adhesion(s) 10759 10764
No Code Available 7662 7664
Unspecified Infection 7014 7018
Inflammation 3153 3156
Not Applicable 2853 2853
Abdominal Pain 2748 2751
Obstruction/Occlusion 2326 2326
Abscess 2250 2252
Erosion 2061 2063
Scarring 1746 1748
Seroma 1687 1690
Nausea 1473 1474
Fistula 1322 1324
Discomfort 1173 1174
Impaired Healing 1108 1111
Purulent Discharge 1101 1101
Scar Tissue 1012 1012
Discharge 896 896
Failure of Implant 869 870
No Information 848 849
Abdominal Distention 800 800
Hematoma 753 753
Swelling 732 732
Incontinence 727 727
Foreign Body Reaction 693 695
Blood Loss 667 667
Necrosis 659 659
No Consequences Or Impact To Patient 646 646
Nerve Damage 609 611
Emotional Changes 558 559
Vomiting 527 528
Ascites 515 515
Fibrosis 490 490
Other (for use when an appropriate patient code cannot be identified) 444 444
Prolapse 436 436
Fever 374 374
Deformity/ Disfigurement 343 343
Urinary Tract Infection 310 310
Bacterial Infection 296 296
Wound Dehiscence 295 295
Diarrhea 290 290
Cellulitis 264 264
Bowel Perforation 250 250
Granuloma 244 245
Sepsis 232 233
No Known Impact Or Consequence To Patient 231 231
Erythema 224 224
Urinary Retention 219 219
Fluid Discharge 218 218
Constipation 217 217
Hemorrhage/Bleeding 216 216
Reaction 211 212
Post Operative Wound Infection 203 204
Death 201 201
Staphylococcus Aureus 196 196
Edema 188 189
Chills 187 187
Surgical procedure 184 184
Complaint, Ill-Defined 183 183
Urinary Frequency 181 181
Internal Organ Perforation 178 178
Weight Changes 176 176
Perforation 175 175
Tissue Damage 171 173
Burning Sensation 167 167
Foreign Body In Patient 164 164
Ischemia 138 138
Micturition Urgency 125 125
Rash 120 120
Hematuria 118 118
Cyst(s) 111 111
Abnormal Vaginal Discharge 110 110
Distress 106 106
Weakness 102 102
Ambulation Difficulties 98 98
Dysuria 94 94
Depression 94 94
Fatigue 84 84
Itching Sensation 82 82
Cramp(s) 76 76
Numbness 75 75
Anxiety 75 75
Peritonitis 72 72
Strangulation 68 68
Patient Problem/Medical Problem 66 66
Therapeutic Response, Decreased 64 64
Hypersensitivity/Allergic reaction 62 63
Low Blood Pressure/ Hypotension 57 58
Corneal Pannus 57 57
Neuropathy 57 57
Ulcer 57 57
Ulceration 56 56
Anemia 56 57
Excessive Tear Production 55 55
Tachycardia 54 54
No Patient Involvement 43 43

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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