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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
AROA BIOSURGERY LTD.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
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
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
XIROS LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 3929 3929
2018 11873 11873
2019 21721 21721
2020 18816 18816
2021 16292 16292

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Device 38269 38269
Insufficient Information 32269 32269
Adverse Event Without Identified Device or Use Problem 25609 25609
Patient Device Interaction Problem 9705 9705
Migration or Expulsion of Device 3428 3428
Appropriate Term/Code Not Available 2676 2676
Patient-Device Incompatibility 1183 1183
Mechanics Altered 844 844
Material Deformation 724 724
Material Split, Cut or Torn 567 567
Loss of or Failure to Bond 516 516
Material Integrity Problem 502 502
Material Erosion 496 496
Detachment of Device or Device Component 291 291
Migration 262 262
Degraded 220 220
No Apparent Adverse Event 153 153
Material Perforation 150 150
Material Separation 127 127
Break 122 122
Material Protrusion/Extrusion 84 84
Device Operates Differently Than Expected 81 81
Therapeutic or Diagnostic Output Failure 79 79
Product Quality Problem 74 74
Torn Material 73 73
Use of Device Problem 70 70
Contamination 63 63
Microbial Contamination of Device 60 60
Expiration Date Error 38 38
Material Twisted/Bent 36 36
Tear, Rip or Hole in Device Packaging 35 35
Device Markings/Labelling Problem 31 31
Packaging Problem 30 30
Improper or Incorrect Procedure or Method 29 29
Folded 28 28
Delivered as Unsterile Product 27 27
Detachment Of Device Component 27 27
Material Frayed 26 26
Hole In Material 26 26
Failure To Adhere Or Bond 25 25
Extrusion 25 25
Material Disintegration 24 24
Entrapment of Device 23 23
Device Contamination with Chemical or Other Material 23 23
Device Dislodged or Dislocated 23 23
Unsealed Device Packaging 20 20
Unexpected Therapeutic Results 19 19
Defective Component 18 18
Deformation Due to Compressive Stress 18 18
Structural Problem 18 18
Peeled/Delaminated 15 15
Material Fragmentation 13 13
Shelf Life Exceeded 13 13
Loosening of Implant Not Related to Bone-Ingrowth 13 13
Physical Resistance/Sticking 12 12
Output Problem 12 12
Failure to Osseointegrate 12 12
Device Appears to Trigger Rejection 12 12
Device Expiration Issue 12 12
Loose or Intermittent Connection 11 11
Material Puncture/Hole 11 11
Human-Device Interface Problem 11 11
Nonstandard Device 9 9
Difficult to Remove 9 9
Sticking 9 9
Contamination /Decontamination Problem 8 8
Delamination 8 8
Unintended Movement 8 8
Device Damaged by Another Device 7 7
Malposition of Device 7 7
Material Too Rigid or Stiff 7 7
Off-Label Use 6 6
Retraction Problem 6 6
Component Missing 6 6
Obstruction of Flow 6 6
Positioning Problem 6 6
Expulsion 6 6
Protective Measures Problem 4 4
Difficult to Open or Close 4 4
Device Issue 4 4
Inadequacy of Device Shape and/or Size 4 4
Device Slipped 4 4
Incorrect, Inadequate or Imprecise Resultor Readings 4 4
Material Rupture 3 3
Unraveled Material 3 3
Mechanical Problem 3 3
Fracture 3 3
Inflation Problem 3 3
Crack 3 3
Difficult or Delayed Positioning 3 3
Bent 3 3
Biocompatibility 3 3
Device-Device Incompatibility 3 3
Device Contaminated During Manufacture or Shipping 3 3
Compatibility Problem 2 2
Device Fell 2 2
Impedance Problem 2 2
Device Or Device Fragments Location Unknown 2 2
Wrinkled 2 2
Disconnection 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 42206 42206
Pain 36645 36657
Disability 17914 17914
Hernia 17183 17188
Adhesion(s) 14648 14657
Unspecified Infection 8212 8220
Insufficient Information 8163 8163
No Code Available 6369 6371
Inflammation 4715 4718
Unspecified Tissue Injury 4685 4685
Abdominal Pain 3428 3431
Obstruction/Occlusion 3110 3110
Not Applicable 3011 3011
Abscess 2998 3000
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2396 2396
Seroma 2140 2144
Discomfort 2124 2125
Nausea 2124 2125
Scar Tissue 1955 1955
Erosion 1833 1835
Scarring 1748 1750
Fistula 1682 1687
Failure of Implant 1428 1429
Impaired Healing 1400 1403
Purulent Discharge 1318 1318
Emotional Changes 1194 1195
Abdominal Distention 989 989
Foreign Body Reaction 958 960
Necrosis 912 912
Discharge 900 900
Hematoma 874 874
Nerve Damage 759 761
No Information 708 708
Fluid Discharge 675 675
Swelling 675 676
Ascites 667 667
Fibrosis 659 659
Diarrhea 638 638
Vomiting 609 610
Blood Loss 600 600
No Consequences Or Impact To Patient 582 582
Chills 529 529
Deformity/ Disfigurement 475 475
Weight Changes 437 437
Bacterial Infection 421 421
No Clinical Signs, Symptoms or Conditions 409 409
Fever 405 405
Incontinence 391 391
Wound Dehiscence 376 376
Decreased Appetite 352 352
Swelling/ Edema 349 349
Hemorrhage/Bleeding 316 316
Granuloma 303 304
Cellulitis 302 302
Prolapse 284 284
Erythema 275 275
Bowel Perforation 253 253
Sepsis 246 248
Urinary Tract Infection 244 244
Constipation 242 242
Post Operative Wound Infection 235 236
Perforation 229 229
Urinary Retention 215 215
Death 199 199
Staphylococcus Aureus 195 195
Distress 195 195
Edema 191 192
Foreign Body In Patient 186 186
Internal Organ Perforation 184 184
Burning Sensation 174 174
Ischemia 171 171
Reaction 169 171
Tissue Damage 150 153
No Known Impact Or Consequence To Patient 150 150
Cyst(s) 145 145
Urinary Frequency 128 128
Depression 107 107
Rash 105 105
Micturition Urgency 103 103
Hematuria 98 98
Muscle Weakness 96 96
Fatigue 95 95
Weakness 95 95
Numbness 92 92
Ulcer 91 91
Abnormal Vaginal Discharge 85 85
Ambulation Difficulties 83 84
Skin Inflammation/ Irritation 80 80
Anxiety 79 79
Dysuria 78 78
Peritonitis 76 76
Hypersensitivity/Allergic reaction 75 76
Itching Sensation 74 74
Neuropathy 73 73
Corneal Pannus 70 70
Strangulation 68 68
Tachycardia 66 66
Cramp(s) 66 66
Low Blood Pressure/ Hypotension 64 65
Anemia 59 60

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 Sofradim Production II Apr-26-2018
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