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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 5
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 1245 1245

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Device 27361 27362
Patient Device Interaction Problem 27039 27040
Adverse Event Without Identified Device or Use Problem 16895 16902
Patient-Device Incompatibility 3914 3919
Mechanics Altered 2882 2882
Insufficient Information 2560 2561
Migration or Expulsion of Device 1916 1918
Material Deformation 872 872
Migration 719 722
Material Split, Cut or Torn 568 568
Appropriate Term/Code Not Available 544 575
Material Integrity Problem 395 395
Degraded 189 189
Detachment of Device or Device Component 116 117
Break 78 78
Delivered as Unsterile Product 78 78
Device Appears to Trigger Rejection 77 77
Device Contamination with Chemical or Other Material 61 61
Expiration Date Error 55 55
Device Markings/Labelling Problem 54 55
Material Separation 52 52
Therapeutic or Diagnostic Output Failure 38 38
Loss of or Failure to Bond 36 36
Use of Device Problem 30 30
Material Protrusion/Extrusion 30 31
Product Quality Problem 28 28
Improper or Incorrect Procedure or Method 26 26
Output Problem 22 22
Material Disintegration 22 22
Material Erosion 19 20
Difficult or Delayed Positioning 16 16
Tear, Rip or Hole in Device Packaging 15 15
Material Twisted/Bent 14 15
Unsealed Device Packaging 14 14
Device Contaminated During Manufacture or Shipping 13 13
Off-Label Use 12 12
Unraveled Material 11 11
Device Dislodged or Dislocated 10 11
Microbial Contamination of Device 10 10
Material Fragmentation 9 9
Packaging Problem 8 8
Difficult to Insert 8 8
Contamination 8 8
Material Frayed 8 8
Entrapment of Device 8 8
Difficult to Remove 7 7
Component Misassembled 7 7
Failure to Osseointegrate 6 6
No Apparent Adverse Event 6 6
Defective Component 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 27098 27100
Pain 21881 21897
Hernia 12264 12280
Adhesion(s) 9811 9829
Unspecified Tissue Injury 8871 8872
Inflammation 4900 4902
Unspecified Infection 4813 4818
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3705 3711
Scar Tissue 3613 3615
Emotional Changes 3086 3086
Discomfort 2950 2952
Distress 2702 2702
Obstruction/Occlusion 2624 2629
Abdominal Pain 2475 2477
Seroma 1906 1907
Abscess 1892 1894
Nausea 1837 1837
Injury 1290 1290
No Clinical Signs, Symptoms or Conditions 1197 1198
Fistula 1109 1112
Diarrhea 1100 1100
Decreased Appetite 1097 1098
Swelling/ Edema 1084 1085
Chills 944 944
Hematoma 915 915
Nerve Damage 891 891
Abdominal Distention 873 873
Erosion 831 832
Hemorrhage/Bleeding 803 804
Weight Changes 799 800
Fluid Discharge 753 754
Impaired Healing 712 712
Purulent Discharge 631 631
Disability 593 593
Foreign Body Reaction 538 540
Necrosis 537 537
Vomiting 526 526
Perforation 509 510
Ascites 472 472
Fibrosis 444 444
Bacterial Infection 434 434
Nodule 432 432
Constipation 426 428
Muscle Weakness 393 393
Failure of Implant 381 384
Erythema 356 357
Wound Dehiscence 335 335
Fever 324 324
Deformity/ Disfigurement 316 316
Hypersensitivity/Allergic reaction 296 296

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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