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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
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
DAVOL INC.
  SUBSTANTIALLY EQUIVALENT 2
DAVOL INC., SUBSIDIARY OF C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
DEEP BLUE MEDICAL ADVANCES, INC.
  SUBSTANTIALLY EQUIVALENT 4
ETHICON, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAST BIOSURGERY
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
SOFRADIM PRODUCTION
  SUBSTANTIALLY EQUIVALENT 5
XIROS LTD
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2020 18815 18815
2021 16284 16284
2022 11439 11439
2023 8025 8025
2024 8569 8584
2025 1689 1690

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Device 38589 38589
Patient Device Interaction Problem 27674 27674
Adverse Event Without Identified Device or Use Problem 21370 21370
Insufficient Information 13505 13505
Mechanics Altered 3752 3752
Migration or Expulsion of Device 2600 2600
Patient-Device Incompatibility 1566 1566
Material Deformation 771 771
Appropriate Term/Code Not Available 723 739
Material Split, Cut or Torn 649 649
Migration 426 426
Material Integrity Problem 407 407
Degraded 249 249
Detachment of Device or Device Component 155 155
Therapeutic or Diagnostic Output Failure 79 79
Break 75 75
Delivered as Unsterile Product 74 74
Material Separation 65 65
Expiration Date Error 63 63
Material Protrusion/Extrusion 51 51
Device Markings/Labelling Problem 51 51
Loss of or Failure to Bond 50 50
Device Contamination with Chemical or Other Material 46 46
Material Erosion 39 39
Product Quality Problem 35 35
Device Appears to Trigger Rejection 30 30
Material Twisted/Bent 28 28
Use of Device Problem 27 27
Improper or Incorrect Procedure or Method 26 26
Material Disintegration 23 23
Output Problem 22 22
Packaging Problem 22 22
Microbial Contamination of Device 17 17
Off-Label Use 16 16
Tear, Rip or Hole in Device Packaging 16 16
Device Dislodged or Dislocated 13 13
Unsealed Device Packaging 13 13
Unraveled Material 11 11
Failure to Osseointegrate 11 11
Entrapment of Device 9 9
Difficult to Insert 9 9
Structural Problem 9 9
Contamination 9 9
Difficult or Delayed Positioning 8 8
Difficult to Remove 8 8
Device Contaminated During Manufacture or Shipping 8 8
Material Frayed 8 8
Material Fragmentation 7 7
Defective Component 5 5
No Apparent Adverse Event 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 28855 28860
Insufficient Information 26770 26770
Injury 15680 15680
Hernia 13593 13599
Adhesion(s) 11646 11657
Unspecified Tissue Injury 10016 10016
Inflammation 6414 6414
Unspecified Infection 6093 6094
Disability 5532 5532
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4262 4262
Scar Tissue 4071 4071
Emotional Changes 3599 3599
Discomfort 3303 3303
Obstruction/Occlusion 3157 3158
Abdominal Pain 2955 2955
Nausea 2321 2321
Distress 2260 2260
Abscess 2217 2217
Seroma 2133 2133
Fistula 1334 1334
Diarrhea 1271 1271
No Clinical Signs, Symptoms or Conditions 1232 1232
Swelling/ Edema 1165 1165
Decreased Appetite 1143 1143
Erosion 1070 1070
Abdominal Distention 1046 1046
Chills 1039 1039
Hematoma 1013 1013
Fluid Discharge 972 972
Hemorrhage/Bleeding 915 915
Impaired Healing 906 906
Weight Changes 865 865
Purulent Discharge 825 825
Nerve Damage 820 820
Failure of Implant 817 817
Foreign Body Reaction 807 807
No Code Available 781 781
Vomiting 687 687
Necrosis 675 675
Not Applicable 629 629
Fibrosis 614 614
Ascites 592 592
Perforation 588 588
Constipation 492 492
Nodule 491 491
Bacterial Infection 486 486
Muscle Weakness 469 469
Scarring 451 451
Deformity/ Disfigurement 418 418
Erythema 388 388

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 Ethicon, Inc. II Dec-03-2020
6 W.L. Gore & Associates, Inc. II Aug-06-2024
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