Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 6
XIROS, LTD.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2021 16284 16292
2022 11439 11449
2023 8025 8027
2024 8567 8583
2025 3558 3575
2026 1493 1493

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Device 27361 27362
Patient Device Interaction Problem 27078 27079
Adverse Event Without Identified Device or Use Problem 17039 17046
Patient-Device Incompatibility 4374 4379
Mechanics Altered 2882 2882
Insufficient Information 2687 2688
Migration or Expulsion of Device 2005 2007
Material Deformation 942 942
Migration 793 796
Material Split, Cut or Torn 580 580
Appropriate Term/Code Not Available 544 575
Material Integrity Problem 429 429
Degraded 192 192
Detachment of Device or Device Component 116 117
Device Appears to Trigger Rejection 90 90
Delivered as Unsterile Product 79 79
Break 79 79
Device Contamination with Chemical or Other Material 65 65
Device Markings/Labelling Problem 55 56
Expiration Date Error 55 55
Material Separation 53 53
Therapeutic or Diagnostic Output Failure 38 38
Loss of or Failure to Bond 36 36
Use of Device Problem 31 31
Material Protrusion/Extrusion 30 31
Product Quality Problem 28 28
Improper or Incorrect Procedure or Method 27 27
Output Problem 22 22
Material Disintegration 22 22
Material Erosion 19 20
Difficult or Delayed Positioning 17 17
Unsealed Device Packaging 16 16
Tear, Rip or Hole in Device Packaging 15 15
Material Twisted/Bent 14 15
Device Contaminated During Manufacture or Shipping 13 13
Off-Label Use 12 12
Unraveled Material 11 11
Device Dislodged or Dislocated 10 11
Microbial Contamination of Device 10 10
Material Fragmentation 9 9
Packaging Problem 8 8
Entrapment of Device 8 8
Contamination 8 8
Difficult to Insert 8 8
Material Frayed 8 8
Component Misassembled 7 7
Difficult to Remove 7 7
Failure to Osseointegrate 6 6
No Apparent Adverse Event 6 6
Structural Problem 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 27155 27157
Pain 22341 22357
Hernia 12901 12917
Adhesion(s) 10242 10260
Unspecified Tissue Injury 8957 8958
Unspecified Infection 4957 4962
Inflammation 4953 4955
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3747 3753
Scar Tissue 3701 3703
Emotional Changes 3119 3119
Discomfort 2989 2991
Distress 2742 2742
Obstruction/Occlusion 2699 2704
Abdominal Pain 2567 2569
Seroma 1979 1980
Abscess 1945 1947
Nausea 1845 1845
Injury 1290 1290
No Clinical Signs, Symptoms or Conditions 1219 1220
Fistula 1132 1135
Diarrhea 1109 1109
Decreased Appetite 1100 1101
Swelling/ Edema 1098 1099
Chills 944 944
Hematoma 942 942
Nerve Damage 935 935
Abdominal Distention 889 889
Erosion 845 846
Hemorrhage/Bleeding 821 822
Weight Changes 799 800
Fluid Discharge 776 777
Impaired Healing 739 739
Purulent Discharge 637 637
Disability 593 593
Necrosis 556 556
Foreign Body Reaction 547 549
Perforation 542 543
Vomiting 531 531
Ascites 480 480
Fibrosis 456 456
Bacterial Infection 440 440
Nodule 439 439
Constipation 434 436
Muscle Weakness 396 396
Failure of Implant 381 384
Erythema 358 359
Wound Dehiscence 339 339
Fever 336 336
Deformity/ Disfigurement 319 319
Hypersensitivity/Allergic reaction 297 297

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
-
-