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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 2391 2391
2017 3927 3927
2018 11866 11866
2019 21720 21720
2020 18814 18814
2021 1026 1026

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 31849 31849
Defective Device 29733 29733
Adverse Event Without Identified Device or Use Problem 21007 21007
Appropriate Term/Code Not Available 3189 3189
Migration or Expulsion of Device 2811 2811
Patient Device Interaction Problem 974 974
Patient-Device Incompatibility 782 782
Material Deformation 558 558
Material Erosion 516 516
Loss of or Failure to Bond 509 509
Material Split, Cut or Torn 441 441
Material Integrity Problem 369 369
Detachment of Device or Device Component 266 266
Degraded 154 154
Material Perforation 149 149
Break 145 145
No Apparent Adverse Event 138 138
Migration 136 136
Material Separation 120 120
Device Operates Differently Than Expected 119 119
Torn Material 91 91
Use of Device Problem 78 78
Material Protrusion/Extrusion 72 72
Therapeutic or Diagnostic Output Failure 67 67
Product Quality Problem 67 67
Contamination 60 60
Microbial Contamination of Device 57 57
Extrusion 54 54
Hole In Material 48 48
Failure To Adhere Or Bond 44 44
Tear, Rip or Hole in Device Packaging 44 44
Mechanics Altered 40 40
Detachment Of Device Component 37 37
Folded 36 36
Packaging Problem 32 32
Improper or Incorrect Procedure or Method 29 29
Device Markings/Labelling Problem 28 28
Material Frayed 26 26
Expiration Date Error 26 26
Unsealed Device Packaging 25 25
Material Disintegration 25 25
Material Twisted/Bent 25 25
Deformation Due to Compressive Stress 23 23
Entrapment of Device 22 22
Unexpected Therapeutic Results 21 21
Device Dislodged or Dislocated 21 21
Nonstandard Device 18 18
Defective Component 18 18
Device Contamination with Chemical or Other Material 18 18
Peeled/Delaminated 14 14
Shelf Life Exceeded 14 14
Structural Problem 14 14
Device Expiration Issue 13 13
Loosening of Implant Not Related to Bone-Ingrowth 12 12
Material Rupture 12 12
Physical Resistance/Sticking 12 12
Loose or Intermittent Connection 11 11
Sticking 10 10
Material Puncture/Hole 10 10
Difficult to Remove 10 10
Material Fragmentation 10 10
Human-Device Interface Problem 10 10
Delamination 10 10
Failure to Osseointegrate 9 9
Material Too Rigid or Stiff 8 8
Device Damaged by Another Device 8 8
Incorrect, Inadequate or Imprecise Resultor Readings 8 8
Delivered as Unsterile Product 8 8
Device Appears to Trigger Rejection 8 8
Unintended Movement 7 7
Contamination /Decontamination Problem 7 7
Device Slipped 7 7
Device Issue 6 6
Obstruction of Flow 6 6
Retraction Problem 6 6
Malposition of Device 6 6
Positioning Problem 6 6
Component Missing 5 5
Difficult to Open or Close 5 5
Expulsion 4 4
Off-Label Use 4 4
Ring 4 4
Protective Measures Problem 4 4
Inadequacy of Device Shape and/or Size 4 4
Unraveled Material 3 3
Kinked 3 3
Difficult or Delayed Positioning 3 3
Device-Device Incompatibility 3 3
Biocompatibility 3 3
Bent 3 3
Crack 3 3
Mechanical Problem 3 3
Inflation Problem 3 3
Device Emits Odor 3 3
Difficult To Position 2 2
Fracture 2 2
Explanted 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 41687 41687
Pain 29645 29649
Disability 17566 17566
Hernia 13786 13790
Adhesion(s) 11673 11678
No Code Available 7309 7311
Unspecified Infection 7174 7178
Inflammation 3540 3543
Not Applicable 3015 3015
Abdominal Pain 2905 2908
Obstruction/Occlusion 2461 2461
Abscess 2369 2371
Scarring 1793 1795
Seroma 1765 1768
Erosion 1650 1652
Nausea 1616 1617
Discomfort 1396 1397
Fistula 1367 1369
Impaired Healing 1193 1196
Purulent Discharge 1151 1151
Scar Tissue 1132 1132
Failure of Implant 969 970
No Information 915 916
Discharge 912 912
Unspecified Tissue Injury 855 855
Abdominal Distention 848 848
Foreign Body Reaction 768 770
Hematoma 756 756
Swelling 709 709
Necrosis 698 698
No Consequences Or Impact To Patient 649 649
Blood Loss 636 636
Nerve Damage 623 625
Emotional Changes 586 587
Ascites 534 534
Fibrosis 533 533
Vomiting 530 531
Incontinence 522 522
Prolapse 402 402
Fever 369 369
Diarrhea 356 356
Deformity/ Disfigurement 354 354
Bacterial Infection 299 299
Wound Dehiscence 297 297
Fluid Discharge 286 286
Urinary Tract Infection 278 278
Cellulitis 267 267
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 256 256
Granuloma 252 253
Chills 248 248
Erythema 236 236
Bowel Perforation 229 229
Weight Changes 223 223
Sepsis 222 223
Urinary Retention 209 209
Constipation 209 209
Hemorrhage/Bleeding 208 208
Staphylococcus Aureus 200 200
Death 197 197
Post Operative Wound Infection 197 198
Edema 192 193
No Known Impact Or Consequence To Patient 186 186
Reaction 183 184
Perforation 182 182
Urinary Frequency 170 170
Internal Organ Perforation 164 164
Foreign Body In Patient 164 164
Burning Sensation 160 160
Tissue Damage 158 160
Ischemia 149 149
Distress 118 118
Cyst(s) 117 117
Micturition Urgency 113 113
Hematuria 109 109
Rash 106 106
Complaint, Ill-Defined 98 98
Weakness 98 98
Depression 97 97
Abnormal Vaginal Discharge 86 86
Ambulation Difficulties 86 86
Dysuria 85 85
Fatigue 82 82
Itching Sensation 76 76
Cramp(s) 73 73
Anxiety 72 72
Peritonitis 70 70
Numbness 70 70
Strangulation 68 68
Ulcer 63 63
Patient Problem/Medical Problem 63 63
Neuropathy 60 60
Corneal Pannus 59 59
Low Blood Pressure/ Hypotension 59 60
Ulceration 59 59
Tachycardia 59 59
Anemia 58 59
Hypersensitivity/Allergic reaction 57 58
Therapeutic Response, Decreased 55 55
Excessive Tear Production 52 52
Hypoesthesia 47 47

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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