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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., 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 4
XIROS LTD
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2020 18815 18815
2021 16284 16284
2022 11439 11439
2023 8026 8026
2024 8569 8584
2025 490 491

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Device 38296 38296
Patient Device Interaction Problem 27402 27402
Adverse Event Without Identified Device or Use Problem 20565 20565
Insufficient Information 13493 13493
Mechanics Altered 3560 3560
Migration or Expulsion of Device 2539 2539
Patient-Device Incompatibility 1284 1284
Appropriate Term/Code Not Available 717 733
Material Deformation 688 688
Material Split, Cut or Torn 614 614
Material Integrity Problem 388 388
Migration 363 363
Degraded 233 233
Detachment of Device or Device Component 144 144
Therapeutic or Diagnostic Output Failure 78 78
Delivered as Unsterile Product 72 72
Break 72 72
Material Separation 65 65
Expiration Date Error 63 63
Material Protrusion/Extrusion 51 51
Loss of or Failure to Bond 50 50
Device Markings/Labelling Problem 48 48
Device Contamination with Chemical or Other Material 39 39
Material Erosion 39 39
Product Quality Problem 31 31
Material Twisted/Bent 28 28
Use of Device Problem 26 26
Improper or Incorrect Procedure or Method 25 25
Material Disintegration 23 23
Device Appears to Trigger Rejection 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 13 13
Device Dislodged or Dislocated 12 12
Failure to Osseointegrate 11 11
Unsealed Device Packaging 10 10
Difficult to Insert 9 9
Unraveled Material 9 9
Entrapment of Device 9 9
Contamination 9 9
Structural Problem 9 9
Difficult to Remove 8 8
Material Frayed 8 8
Material Fragmentation 7 7
Difficult or Delayed Positioning 6 6
Defective Component 5 5
No Apparent Adverse Event 5 5
Unexpected Therapeutic Results 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 28222 28226
Insufficient Information 26412 26412
Injury 15680 15680
Hernia 12958 12964
Adhesion(s) 11191 11202
Unspecified Tissue Injury 9563 9563
Inflammation 6257 6257
Unspecified Infection 5897 5898
Disability 5532 5532
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4139 4139
Scar Tissue 3920 3920
Emotional Changes 3488 3488
Discomfort 3047 3047
Obstruction/Occlusion 3020 3021
Abdominal Pain 2779 2779
Nausea 2248 2248
Abscess 2136 2136
Seroma 2046 2046
Distress 1983 1983
Fistula 1280 1280
Diarrhea 1254 1254
No Clinical Signs, Symptoms or Conditions 1178 1178
Decreased Appetite 1129 1129
Swelling/ Edema 1094 1094
Erosion 1044 1044
Chills 1035 1035
Abdominal Distention 990 990
Hematoma 936 936
Fluid Discharge 928 928
Impaired Healing 870 870
Weight Changes 863 863
Hemorrhage/Bleeding 861 861
Failure of Implant 814 814
Nerve Damage 796 796
No Code Available 781 781
Purulent Discharge 777 777
Foreign Body Reaction 771 771
Vomiting 641 641
Necrosis 639 639
Not Applicable 629 629
Ascites 562 562
Fibrosis 560 560
Perforation 560 560
Nodule 459 459
Bacterial Infection 457 457
Scarring 451 451
Constipation 449 449
Muscle Weakness 430 430
Deformity/ Disfigurement 416 416
Erythema 366 366

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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