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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 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
XIROS LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 2392 2392
2017 3929 3929
2018 11872 11872
2019 21720 21720
2020 18816 18816
2021 13519 13519

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Device 37008 37008
Insufficient Information 32926 32926
Adverse Event Without Identified Device or Use Problem 25358 25358
Patient Device Interaction Problem 7717 7717
Migration or Expulsion of Device 3360 3360
Appropriate Term/Code Not Available 3290 3290
Patient-Device Incompatibility 1054 1054
Material Deformation 659 659
Material Erosion 530 530
Material Split, Cut or Torn 530 530
Loss of or Failure to Bond 515 515
Material Integrity Problem 449 449
Detachment of Device or Device Component 306 306
Mechanics Altered 253 253
Migration 213 213
Degraded 195 195
No Apparent Adverse Event 153 153
Break 151 151
Material Perforation 150 150
Material Separation 131 131
Device Operates Differently Than Expected 120 120
Torn Material 91 91
Therapeutic or Diagnostic Output Failure 86 86
Material Protrusion/Extrusion 86 86
Use of Device Problem 79 79
Product Quality Problem 74 74
Contamination 67 67
Microbial Contamination of Device 62 62
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
Expiration Date Error 36 36
Material Twisted/Bent 36 36
Folded 36 36
Packaging Problem 33 33
Improper or Incorrect Procedure or Method 31 31
Device Markings/Labelling Problem 31 31
Material Disintegration 29 29
Material Frayed 28 28
Unsealed Device Packaging 25 25
Device Dislodged or Dislocated 25 25
Deformation Due to Compressive Stress 23 23
Delivered as Unsterile Product 23 23
Entrapment of Device 23 23
Unexpected Therapeutic Results 21 21
Device Contamination with Chemical or Other Material 21 21
Defective Component 18 18
Structural Problem 18 18
Nonstandard Device 18 18
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 12 12
Material Puncture/Hole 11 11
Difficult to Remove 10 10
Delamination 10 10
Human-Device Interface Problem 10 10
Sticking 10 10
Device Appears to Trigger Rejection 9 9
Unintended Movement 9 9
Failure to Osseointegrate 9 9
Material Too Rigid or Stiff 9 9
Incorrect, Inadequate or Imprecise Resultor Readings 8 8
Device Damaged by Another Device 8 8
Contamination /Decontamination Problem 8 8
Positioning Problem 7 7
Malposition of Device 7 7
Device Slipped 7 7
Retraction Problem 6 6
Expulsion 6 6
Component Missing 6 6
Device Issue 6 6
Obstruction of Flow 6 6
Difficult to Open or Close 5 5
Off-Label Use 5 5
Protective Measures Problem 4 4
Output Problem 4 4
Inadequacy of Device Shape and/or Size 4 4
Biocompatibility 3 3
Unraveled Material 3 3
Kinked 3 3
Leak/Splash 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 42529 42529
Pain 35248 35261
Disability 17963 17963
Hernia 16429 16434
Adhesion(s) 14079 14088
Unspecified Infection 8089 8096
No Code Available 7311 7314
Insufficient Information 6489 6489
Inflammation 4483 4486
Abdominal Pain 3343 3346
Unspecified Tissue Injury 3054 3054
Not Applicable 3017 3017
Obstruction/Occlusion 2930 2931
Abscess 2862 2864
Seroma 2098 2102
Nausea 2019 2020
Discomfort 1975 1976
Erosion 1903 1905
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1866 1866
Scarring 1794 1796
Scar Tissue 1696 1696
Fistula 1605 1609
Impaired Healing 1357 1360
Purulent Discharge 1296 1296
Failure of Implant 1263 1264
Abdominal Distention 964 964
No Information 922 923
Discharge 912 912
Foreign Body Reaction 904 906
Hematoma 874 874
Necrosis 851 851
Emotional Changes 748 749
Nerve Damage 739 742
Swelling 710 711
No Consequences Or Impact To Patient 652 652
Ascites 645 645
Fibrosis 637 637
Blood Loss 636 636
Vomiting 610 611
Diarrhea 562 562
Incontinence 535 535
Fluid Discharge 506 506
Chills 449 449
Deformity/ Disfigurement 423 423
Prolapse 420 420
Fever 414 414
Bacterial Infection 380 380
Weight Changes 380 381
Wound Dehiscence 366 366
No Clinical Signs, Symptoms or Conditions 326 326
Urinary Tract Infection 308 308
Cellulitis 303 303
Granuloma 296 297
Hemorrhage/Bleeding 292 292
Decreased Appetite 266 266
Erythema 264 264
Sepsis 252 254
Bowel Perforation 251 251
Urinary Retention 247 247
Constipation 243 243
Post Operative Wound Infection 240 241
Swelling/ Edema 238 238
Perforation 218 218
Death 208 208
Staphylococcus Aureus 200 200
Edema 192 193
No Known Impact Or Consequence To Patient 186 186
Foreign Body In Patient 185 185
Reaction 184 186
Burning Sensation 183 183
Internal Organ Perforation 181 181
Urinary Frequency 178 178
Ischemia 172 172
Tissue Damage 160 163
Distress 150 150
Cyst(s) 140 140
Micturition Urgency 121 121
Hematuria 114 114
Rash 112 112
Depression 107 107
Complaint, Ill-Defined 98 98
Weakness 98 98
Ambulation Difficulties 96 97
Dysuria 94 94
Abnormal Vaginal Discharge 93 93
Fatigue 93 94
Numbness 92 92
Itching Sensation 79 79
Peritonitis 77 77
Hypersensitivity/Allergic reaction 77 78
Ulcer 76 76
Anxiety 74 75
Cramp(s) 73 73
Neuropathy 71 71
Corneal Pannus 70 70
Strangulation 68 68
Low Blood Pressure/ Hypotension 65 66
Tachycardia 65 65
Patient Problem/Medical Problem 63 63
Muscle Weakness 62 62

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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