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

MDR Year MDR Reports MDR Events
2019 21721 21721
2020 18816 18816
2021 16284 16284
2022 11439 11439
2023 8025 8025
2024 6738 6738

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Device 50222 50222
Patient Device Interaction Problem 27663 27663
Insufficient Information 26763 26763
Adverse Event Without Identified Device or Use Problem 26378 26378
Mechanics Altered 4165 4165
Migration or Expulsion of Device 3603 3603
Patient-Device Incompatibility 1399 1399
Material Deformation 842 842
Appropriate Term/Code Not Available 831 831
Material Split, Cut or Torn 785 785
Material Integrity Problem 551 551
Loss of or Failure to Bond 392 392
Migration 371 371
Degraded 308 308
Material Erosion 298 298
Detachment of Device or Device Component 216 216
Therapeutic or Diagnostic Output Failure 91 91
Material Perforation 88 88
Material Separation 78 78
Expiration Date Error 67 67
Material Protrusion/Extrusion 64 64
Break 64 64
Delivered as Unsterile Product 62 62
Product Quality Problem 55 55
Device Markings/Labelling Problem 44 44
Device Contamination with Chemical or Other Material 43 43
No Apparent Adverse Event 42 42
Use of Device Problem 38 38
Improper or Incorrect Procedure or Method 34 34
Microbial Contamination of Device 33 33
Material Twisted/Bent 31 31
Packaging Problem 29 29
Material Disintegration 23 23
Output Problem 22 22
Contamination 21 21
Device Appears to Trigger Rejection 19 19
Tear, Rip or Hole in Device Packaging 18 18
Off-Label Use 16 16
Device Dislodged or Dislocated 16 16
Unsealed Device Packaging 16 16
Unexpected Therapeutic Results 16 16
Material Frayed 16 16
Structural Problem 15 15
Entrapment of Device 13 13
Peeled/Delaminated 12 12
Failure to Osseointegrate 11 11
Human-Device Interface Problem 9 9
Difficult to Insert 9 9
Material Fragmentation 8 8
Unraveled Material 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 39305 39309
Injury 32847 32847
Insufficient Information 25802 25802
Hernia 17095 17098
Adhesion(s) 14968 14973
Disability 12820 12820
Unspecified Tissue Injury 10965 10965
Unspecified Infection 8091 8094
Inflammation 7776 7778
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4619 4619
Scar Tissue 4574 4574
Emotional Changes 4262 4263
Obstruction/Occlusion 3774 3774
Abdominal Pain 3647 3648
Discomfort 3447 3447
Abscess 3062 3064
Nausea 2774 2774
Seroma 2736 2738
No Code Available 2527 2528
Distress 1900 1900
Fistula 1712 1714
No Clinical Signs, Symptoms or Conditions 1657 1657
Not Applicable 1604 1604
Erosion 1574 1576
Abdominal Distention 1381 1381
Diarrhea 1322 1322
Impaired Healing 1311 1313
Fluid Discharge 1279 1279
Hematoma 1194 1194
Purulent Discharge 1180 1180
Decreased Appetite 1143 1143
Scarring 1121 1122
Chills 1107 1107
Foreign Body Reaction 1089 1091
Failure of Implant 1077 1078
Swelling/ Edema 1050 1050
Nerve Damage 1034 1035
Hemorrhage/Bleeding 964 964
Weight Changes 921 921
Necrosis 904 904
Ascites 829 829
Fibrosis 758 758
Vomiting 754 754
Perforation 642 642
Deformity/ Disfigurement 585 585
Bacterial Infection 581 581
Discharge 532 532
Constipation 494 494
No Information 486 486
Nodule 474 474

Recalls
Manufacturer Recall Class Date Posted
1 Covidien Llc II Feb-22-2021
2 Covidien, LP II Feb-27-2023
3 Davol, Inc. II Jul-27-2023
4 Ethicon, Inc. II Dec-03-2020
5 W.L. Gore & Associates, Inc. II Aug-06-2024
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