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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 8566 8582
2025 3557 3574
2026 631 631

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Device 27361 27362
Patient Device Interaction Problem 26963 26964
Adverse Event Without Identified Device or Use Problem 16551 16558
Patient-Device Incompatibility 3040 3045
Mechanics Altered 2881 2881
Insufficient Information 2435 2436
Migration or Expulsion of Device 1815 1817
Material Deformation 772 772
Migration 599 602
Material Split, Cut or Torn 553 553
Appropriate Term/Code Not Available 542 573
Material Integrity Problem 349 349
Degraded 184 184
Detachment of Device or Device Component 114 115
Delivered as Unsterile Product 78 78
Break 77 77
Device Contamination with Chemical or Other Material 59 59
Device Appears to Trigger Rejection 56 56
Expiration Date Error 55 55
Device Markings/Labelling Problem 53 54
Material Separation 52 52
Therapeutic or Diagnostic Output Failure 37 37
Loss of or Failure to Bond 36 36
Material Protrusion/Extrusion 29 30
Product Quality Problem 28 28
Use of Device Problem 26 26
Improper or Incorrect Procedure or Method 26 26
Output Problem 22 22
Material Disintegration 21 21
Material Erosion 19 20
Material Twisted/Bent 14 15
Unsealed Device Packaging 14 14
Tear, Rip or Hole in Device Packaging 14 14
Difficult or Delayed Positioning 13 13
Off-Label Use 12 12
Device Contaminated During Manufacture or Shipping 12 12
Unraveled Material 11 11
Device Dislodged or Dislocated 10 11
Microbial Contamination of Device 10 10
Contamination 8 8
Packaging Problem 8 8
Material Frayed 8 8
Difficult to Insert 8 8
Component Misassembled 7 7
Entrapment of Device 7 7
Difficult to Remove 7 7
Material Fragmentation 7 7
Failure to Osseointegrate 6 6
Defective Component 5 5
No Apparent Adverse Event 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 27021 27023
Pain 21012 21028
Hernia 11186 11202
Adhesion(s) 9051 9069
Unspecified Tissue Injury 8676 8677
Inflammation 4828 4830
Unspecified Infection 4567 4572
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3626 3632
Scar Tissue 3413 3415
Emotional Changes 3004 3004
Discomfort 2845 2847
Distress 2610 2610
Obstruction/Occlusion 2469 2474
Abdominal Pain 2328 2330
Nausea 1822 1822
Seroma 1818 1819
Abscess 1760 1762
Injury 1290 1290
No Clinical Signs, Symptoms or Conditions 1160 1161
Decreased Appetite 1091 1092
Diarrhea 1091 1091
Swelling/ Edema 1051 1052
Fistula 1048 1051
Chills 942 942
Hematoma 867 867
Abdominal Distention 840 840
Erosion 814 815
Nerve Damage 804 804
Weight Changes 796 797
Hemorrhage/Bleeding 786 787
Fluid Discharge 727 728
Impaired Healing 694 694
Purulent Discharge 601 601
Disability 593 593
Foreign Body Reaction 518 520
Vomiting 510 510
Necrosis 507 507
Ascites 462 462
Perforation 441 442
Fibrosis 421 421
Bacterial Infection 419 419
Constipation 412 414
Nodule 408 408
Failure of Implant 379 382
Muscle Weakness 378 378
Erythema 335 336
Wound Dehiscence 317 317
Fever 313 313
Deformity/ Disfigurement 312 312
Hypersensitivity/Allergic reaction 289 289

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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