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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
Product CodeFTL
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
ARISTE MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
AROA BIOSURGERY LTD.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
CR BARD INC.
  SUBSTANTIALLY EQUIVALENT 1
DEEP BLUE MEDICAL ADVANCES, INC.
  SUBSTANTIALLY EQUIVALENT 2
ETHICON INC
  SUBSTANTIALLY EQUIVALENT 1
ETHICON, INC
  SUBSTANTIALLY EQUIVALENT 1
ETHICON, INC.
  SUBSTANTIALLY EQUIVALENT 3
EXOGENESIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FEG TEXTILTECHNIK FORSCHUNGS- UND ENTWICKLUNGSGESELLSCHAFT
  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 5
SURGICAL INNOVATION ASSOCIATES, INC.
  SUBSTANTIALLY EQUIVALENT 1
XIROS LTD
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2018 11877 11877
2019 21721 21721
2020 18816 18816
2021 16286 16286
2022 11438 11438

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Device 45080 45080
Insufficient Information 31528 31528
Adverse Event Without Identified Device or Use Problem 27127 27127
Patient Device Interaction Problem 17893 17893
Migration or Expulsion of Device 3930 3930
Mechanics Altered 3159 3159
Appropriate Term/Code Not Available 1962 1962
Patient-Device Incompatibility 1480 1480
Material Deformation 887 887
Material Split, Cut or Torn 696 696
Material Integrity Problem 539 539
Loss of or Failure to Bond 495 495
Material Erosion 416 416
Migration 361 361
Degraded 308 308
Detachment of Device or Device Component 268 268
Material Perforation 134 134
No Apparent Adverse Event 124 124
Material Separation 90 90
Therapeutic or Diagnostic Output Failure 89 89
Material Protrusion/Extrusion 86 86
Break 83 83
Product Quality Problem 72 72
Use of Device Problem 60 60
Microbial Contamination of Device 55 55
Expiration Date Error 50 50
Contamination 48 48
Device Operates Differently Than Expected 45 45
Device Markings/Labelling Problem 40 40
Improper or Incorrect Procedure or Method 37 37
Delivered as Unsterile Product 35 35
Material Twisted/Bent 35 35
Packaging Problem 31 31
Device Contamination with Chemical or Other Material 29 29
Tear, Rip or Hole in Device Packaging 27 27
Torn Material 24 24
Material Disintegration 23 23
Device Dislodged or Dislocated 22 22
Output Problem 21 21
Entrapment of Device 21 21
Material Frayed 19 19
Structural Problem 19 19
Unexpected Therapeutic Results 19 19
Defective Component 18 18
Device Appears to Trigger Rejection 15 15
Physical Resistance/Sticking 14 14
Loosening of Implant Not Related to Bone-Ingrowth 13 13
Unsealed Device Packaging 13 13
Peeled/Delaminated 13 13
Material Fragmentation 11 11
Detachment Of Device Component 11 11
Material Puncture/Hole 11 11
Failure to Osseointegrate 11 11
Deformation Due to Compressive Stress 11 11
Failure To Adhere Or Bond 10 10
Off-Label Use 10 10
Folded 9 9
Extrusion 9 9
Human-Device Interface Problem 8 8
Contamination /Decontamination Problem 8 8
Unintended Movement 8 8
Loose or Intermittent Connection 8 8
Device Expiration Issue 8 8
Nonstandard Device 7 7
Shelf Life Exceeded 7 7
Malposition of Device 7 7
Expulsion 6 6
Retraction Problem 6 6
Difficult to Remove 6 6
Device Slipped 6 6
Component Missing 6 6
Obstruction of Flow 6 6
Sticking 5 5
Device Damaged by Another Device 5 5
Difficult to Open or Close 4 4
Device Contaminated During Manufacture or Shipping 4 4
Positioning Problem 4 4
Protective Measures Problem 4 4
Inadequacy of Device Shape and/or Size 4 4
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Material Too Rigid or Stiff 4 4
Material Rupture 3 3
Unraveled Material 3 3
Mechanical Problem 3 3
Fracture 3 3
Hole In Material 3 3
Inflation Problem 3 3
Crack 3 3
Device-Device Incompatibility 3 3
Compatibility Problem 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Biocompatibility 2 2
Component Misassembled 2 2
Device Fell 2 2
Lack of Effect 2 2
Difficult or Delayed Positioning 2 2
Disconnection 2 2
Inadequate Instructions for Healthcare Professional 2 2
Material Invagination 2 2
Leak/Splash 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 41973 41982
Injury 40945 40945
Hernia 18007 18011
Disability 17374 17374
Adhesion(s) 15995 16004
Insufficient Information 15850 15850
Unspecified Infection 8698 8705
Unspecified Tissue Injury 8539 8539
Inflammation 7176 7179
No Code Available 4866 4868
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3758 3758
Scar Tissue 3630 3630
Obstruction/Occlusion 3623 3623
Abdominal Pain 3548 3551
Emotional Changes 3521 3522
Abscess 3274 3276
Discomfort 2837 2838
Not Applicable 2763 2763
Nausea 2757 2758
Seroma 2447 2450
Erosion 1897 1899
Fistula 1796 1801
Scarring 1587 1589
Impaired Healing 1443 1446
Failure of Implant 1379 1380
Purulent Discharge 1300 1300
Diarrhea 1193 1193
Foreign Body Reaction 1192 1194
Abdominal Distention 1126 1126
Fluid Discharge 1122 1122
No Clinical Signs, Symptoms or Conditions 1048 1048
Chills 1037 1037
Hematoma 958 958
Decreased Appetite 956 956
Nerve Damage 935 937
Necrosis 929 929
Weight Changes 881 881
Discharge 799 799
Ascites 744 744
Fibrosis 713 713
Swelling/ Edema 712 712
Vomiting 632 633
Swelling 571 571
No Information 562 562
Deformity/ Disfigurement 559 559
Hemorrhage/Bleeding 555 555
Bacterial Infection 520 520
Blood Loss 472 472
Distress 459 459
Fever 427 427
Perforation 392 392
No Consequences Or Impact To Patient 387 387
Wound Dehiscence 386 386
Constipation 324 324
Cellulitis 323 323
Incontinence 311 311
Erythema 309 309
Granuloma 301 302
Urinary Tract Infection 258 258
Sepsis 252 253
Muscle Weakness 250 250
Nodule 230 230
Bowel Perforation 229 229
Prolapse 226 226
Urinary Retention 223 223
Post Operative Wound Infection 220 221
Burning Sensation 184 184
Death 183 183
Staphylococcus Aureus 181 181
Ischemia 177 177
Edema 172 173
Foreign Body In Patient 167 167
Internal Organ Perforation 166 166
Cyst(s) 146 146
Depression 143 143
Numbness 139 139
Reaction 137 138
Anxiety 122 122
Hypersensitivity/Allergic reaction 119 120
Ulcer 115 115
No Known Impact Or Consequence To Patient 115 115
Urinary Frequency 114 114
Tissue Damage 112 115
Fatigue 111 111
Cramp(s) /Muscle Spasm(s) 108 108
Rash 98 98
Micturition Urgency 96 96
Skin Inflammation/ Irritation 95 95
Hematuria 93 93
Peritonitis 89 89
Dysuria 87 87
Weakness 81 81
Tachycardia 77 77
Ambulation Difficulties 75 75
Neuropathy 73 73
Low Blood Pressure/ Hypotension 70 71
Abnormal Vaginal Discharge 66 66
Sleep Dysfunction 65 65
Corneal Pannus 62 62
Itching Sensation 58 58

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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