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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
ARISTE MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
DAVOL INC., SUBSIDIARY OF C. R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 3
DAVOL, INC.
  SUBSTANTIALLY EQUIVALENT 2
DEEP BLUE MEDICAL ADVANCES, INC.
  SUBSTANTIALLY EQUIVALENT 3
MAST BIOSURGERY
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC - SOFRADIM PRODUCTION
  SUBSTANTIALLY EQUIVALENT 1
SOFRADIM PRODUCTION
  SUBSTANTIALLY EQUIVALENT 6
XIROS, LTD.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2021 16284 16292
2022 11439 11449
2023 8025 8027
2024 8567 8583
2025 3558 3575
2026 2005 2007

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Device 27323 27323
Patient Device Interaction Problem 27092 27092
Adverse Event Without Identified Device or Use Problem 16804 16808
Patient-Device Incompatibility 4760 4760
Mechanics Altered 2884 2884
Insufficient Device Problem Information 2765 2765
Migration or Expulsion of Device 1980 1980
Material Deformation 979 979
Migration 922 924
Material Split, Cut or Torn 581 581
Material Integrity Problem 437 437
Appropriate Device Problem Term/Code Not Available 324 357
Degraded 194 194
Device Appears to Trigger Rejection 114 114
Detachment of Device or Device Component 102 102
Delivered as Unsterile Product 79 79
Break 71 71
Device Contamination with Chemical or Other Material 67 67
Device Markings/Labelling Problem 60 60
Expiration Date Error 54 54
Material Separation 43 43
Loss of or Failure to Bond 36 36
Product Quality Problem 28 28
Improper or Incorrect Procedure or Method 25 25
Use of Device Problem 25 25
Material Disintegration 21 21
Unsealed Device Packaging 19 19
Difficult or Delayed Positioning 17 17
Tear, Rip or Hole in Device Packaging 15 15
Device Contaminated During Manufacture or Shipping 13 13
Off-Label Use 11 11
Unraveled Material 11 11
Component Misassembled 8 8
Packaging Problem 8 8
Difficult to Insert 8 8
Material Frayed 8 8
Difficult to Remove 7 7
Microbial Contamination of Device 7 7
No Apparent Adverse Event 6 6
Contamination 5 5
Material Protrusion/Extrusion 4 4
Material Erosion 4 4
Biocompatibility 4 4
Human-Device Interface Problem 3 3
Calcified 3 3
Device Damaged by Another Device 3 3
Material Too Rigid or Stiff 3 3
Device Misassembled During Manufacturing /Shipping 3 3
Material Fragmentation 3 3
Therapeutic or Diagnostic Output Failure 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 27279 27281
Pain 22905 22922
Hernia 13961 13978
Adhesion(s) 10949 10968
Unspecified Tissue Injury 9122 9123
Unspecified Infection 5165 5170
Inflammation 5020 5024
Scar Tissue 3907 3911
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 3787 3793
Emotional Changes 3151 3151
Discomfort 3035 3037
Obstruction/Occlusion 2845 2850
Distress 2802 2802
Abdominal Pain 2727 2729
Seroma 2102 2103
Abscess 2020 2022
Nausea 1853 1853
Injury 1290 1290
No Clinical Signs, Symptoms or Conditions 1253 1254
Fistula 1178 1181
Diarrhea 1129 1129
Swelling/ Edema 1117 1118
Decreased Appetite 1103 1104
Nerve Damage 1005 1005
Hematoma 975 975
Chills 944 944
Abdominal Distention 907 907
Hemorrhage/Blood Loss/Bleeding 871 872
Erosion 863 864
Weight Changes 800 801
Fluid Discharge 793 794
Impaired Healing 789 789
Purulent Discharge 665 665
Disability 593 593
Necrosis 576 576
Perforation 557 558
Foreign Body Reaction 553 555
Vomiting 537 537
Ascites 486 486
Fibrosis 480 480
Nodule 459 459
Bacterial Infection 452 452
Constipation 445 447
Muscle Weakness/Atrophy 405 405
Failure of Implant 383 386
Erythema 367 368
Fever 360 360
Wound Dehiscence 347 347
Deformity/ Disfigurement 324 324
Hypersensitivity/Allergic reaction 306 306

Recalls
Manufacturer Recall Class Date Posted
1 Chamberlain Technologies LLC II Jun-17-2025
2 Covidien Llc II Feb-22-2021
3 Covidien, LP II Feb-27-2023
4 Davol, Inc. II Jul-27-2023
5 W.L. Gore & Associates, Inc. II Aug-06-2024
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