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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device mesh, surgical
Regulation Description Surgical mesh.
Product CodeFTM
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
ALAFAIR BIOSCIENCES INC
  SUBSTANTIALLY EQUIVALENT 3
AROA BIOSURGERY LTD.
  SUBSTANTIALLY EQUIVALENT 1
AZIYO BIOLOGICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
B. BRUAN SURGICAL, SA
  SUBSTANTIALLY EQUIVALENT 1
COOK BIOTECH INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
ELUTIA INC.
  SUBSTANTIALLY EQUIVALENT 1
GEISTLICH PHARMA AG
  SUBSTANTIALLY EQUIVALENT 1
SYNOVIS LIFE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNOVIS LIFE TECHNOLOGIES. INC. (A SUBSIDIARY OF BAXTER
  SUBSTANTIALLY EQUIVALENT 1
TELA BIO
  SUBSTANTIALLY EQUIVALENT 1
TELA BIO, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 458 458
2021 369 369
2022 375 375
2023 486 486
2024 383 383
2025 140 140

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1641 1641
Patient Device Interaction Problem 145 145
Insufficient Information 127 127
Defective Device 105 105
Break 89 89
Patient-Device Incompatibility 66 66
Migration or Expulsion of Device 60 60
Migration 33 33
No Apparent Adverse Event 23 23
Mechanics Altered 22 22
Material Disintegration 21 21
Degraded 21 21
Peeled/Delaminated 17 17
Material Split, Cut or Torn 16 16
Material Integrity Problem 15 15
Off-Label Use 10 10
Fluid/Blood Leak 9 9
Appropriate Term/Code Not Available 9 9
Detachment of Device or Device Component 8 8
Tear, Rip or Hole in Device Packaging 8 8
Improper or Incorrect Procedure or Method 7 7
Material Deformation 7 7
Therapeutic or Diagnostic Output Failure 6 6
Contamination /Decontamination Problem 5 5
Compatibility Problem 4 4
Contamination 3 3
Malposition of Device 3 3
Material Separation 3 3
Device Appears to Trigger Rejection 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Discolored 2 2
Material Too Rigid or Stiff 2 2
Use of Device Problem 2 2
Material Twisted/Bent 2 2
Device Damaged Prior to Use 2 2
Product Quality Problem 2 2
Entrapment of Device 2 2
Melted 1 1
Unexpected Therapeutic Results 1 1
Failure to Form Staple 1 1
Fracture 1 1
Difficult to Open or Close 1 1
Failure to Seal 1 1
Material Protrusion/Extrusion 1 1
Device Contamination with Chemical or Other Material 1 1
Inadequacy of Device Shape and/or Size 1 1
Material Rupture 1 1
Material Perforation 1 1
Shipping Damage or Problem 1 1
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hernia 936 936
Adhesion(s) 401 401
Unspecified Infection 280 280
Pain 275 275
Injury 216 216
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 190 190
Seroma 190 190
Unspecified Tissue Injury 183 183
Obstruction/Occlusion 159 159
Abscess 153 153
No Clinical Signs, Symptoms or Conditions 149 149
Insufficient Information 142 142
Bacterial Infection 140 140
Fistula 120 120
Impaired Healing 97 97
Inflammation 85 85
Necrosis 85 85
Fluid Discharge 82 82
Wound Dehiscence 75 75
Failure of Implant 69 69
Erosion 67 67
Hemorrhage/Bleeding 67 67
Abdominal Pain 65 65
Post Operative Wound Infection 65 65
No Code Available 61 61
Scar Tissue 51 51
Discomfort 46 46
Purulent Discharge 43 43
Hematoma 43 43
Foreign Body Reaction 40 40
Perforation 38 38
Fever 34 34
Sepsis 32 32
Abdominal Distention 30 30
Cellulitis 28 28
Erythema 25 25
Incontinence 23 23
Hypersensitivity/Allergic reaction 22 22
Swelling/ Edema 21 21
Urinary Tract Infection 20 20
Nausea 20 20
Capsular Contracture 19 19
Vomiting 19 19
Ascites 17 17
Fibrosis 17 17
Emotional Changes 15 15
Scarring 15 15
Stenosis 14 14
Discharge 14 14
Prolapse 14 14

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Mar-26-2024
2 Baxter Healthcare Corporation II Jan-05-2024
3 Baxter Healthcare Corporation II Jan-08-2021
4 Cook Biotech, Inc. II Sep-25-2024
5 Stryker Leibinger GmbH & Co. KG II Mar-03-2022
6 TEI Biosciences, Inc. II Sep-30-2024
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