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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 18815 18815
2021 16284 16284
2022 11439 11439
2023 8026 8026
2024 7990 8005

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Device 50456 50456
Patient Device Interaction Problem 28013 28013
Adverse Event Without Identified Device or Use Problem 27280 27280
Insufficient Information 26783 26783
Mechanics Altered 4258 4258
Migration or Expulsion of Device 3681 3681
Patient-Device Incompatibility 1427 1427
Material Deformation 893 893
Appropriate Term/Code Not Available 835 850
Material Split, Cut or Torn 811 811
Material Integrity Problem 568 568
Migration 399 399
Loss of or Failure to Bond 392 392
Degraded 319 319
Material Erosion 298 298
Detachment of Device or Device Component 218 218
Therapeutic or Diagnostic Output Failure 92 92
Material Perforation 88 88
Material Separation 80 80
Delivered as Unsterile Product 74 74
Expiration Date Error 71 71
Break 66 66
Material Protrusion/Extrusion 65 65
Product Quality Problem 55 55
Device Markings/Labelling Problem 45 45
No Apparent Adverse Event 44 44
Device Contamination with Chemical or Other Material 44 44
Use of Device Problem 39 39
Improper or Incorrect Procedure or Method 35 35
Microbial Contamination of Device 33 33
Material Twisted/Bent 31 31
Packaging Problem 30 30
Material Disintegration 24 24
Device Appears to Trigger Rejection 23 23
Output Problem 22 22
Contamination 21 21
Tear, Rip or Hole in Device Packaging 19 19
Unsealed Device Packaging 16 16
Material Frayed 16 16
Unexpected Therapeutic Results 16 16
Device Dislodged or Dislocated 16 16
Off-Label Use 16 16
Structural Problem 15 15
Entrapment of Device 13 13
Peeled/Delaminated 12 12
Failure to Osseointegrate 11 11
Unraveled Material 10 10
Human-Device Interface Problem 9 9
Difficult to Insert 9 9
Material Puncture/Hole 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 39809 39817
Injury 32846 32846
Insufficient Information 26136 26136
Hernia 17629 17638
Adhesion(s) 15363 15379
Disability 12820 12820
Unspecified Tissue Injury 11498 11498
Unspecified Infection 8337 8341
Inflammation 8055 8057
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4886 4886
Scar Tissue 4777 4777
Emotional Changes 4357 4358
Obstruction/Occlusion 3983 3984
Abdominal Pain 3927 3928
Discomfort 3658 3658
Abscess 3155 3157
Nausea 2910 2910
Seroma 2897 2899
No Code Available 2527 2528
Distress 2056 2056
Fistula 1793 1795
No Clinical Signs, Symptoms or Conditions 1713 1713
Not Applicable 1604 1604
Erosion 1599 1601
Abdominal Distention 1481 1481
Diarrhea 1375 1375
Impaired Healing 1364 1366
Fluid Discharge 1349 1349
Hematoma 1293 1293
Purulent Discharge 1240 1240
Swelling/ Edema 1237 1237
Decreased Appetite 1180 1180
Foreign Body Reaction 1132 1134
Chills 1124 1124
Scarring 1121 1122
Nerve Damage 1089 1090
Failure of Implant 1087 1088
Hemorrhage/Bleeding 1051 1051
Necrosis 948 948
Weight Changes 938 938
Ascites 887 887
Vomiting 847 847
Fibrosis 802 802
Perforation 715 715
Bacterial Infection 624 624
Deformity/ Disfigurement 605 605
Nodule 560 560
Constipation 558 558
Muscle Weakness 535 535
Discharge 532 532

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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