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, absorbable, abdominal hernia
Regulation Description Surgical mesh.
Definition For reinforcement of soft tissue where weakness exists during hernia repair.
Product CodeOWT
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
DAVOL, INC., A SUBSIDIARY OF C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
SOFRADIM PRODUCTION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 58 58
2022 104 104
2023 76 78
2024 65 67
2025 84 84
2026 39 39

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Device 229 232
Patient Device Interaction Problem 223 226
Patient-Device Incompatibility 118 119
Tear, Rip or Hole in Device Packaging 26 26
Adverse Event Without Identified Device or Use Problem 24 24
Insufficient Information 11 11
Material Separation 5 5
Expiration Date Error 4 4
Device Appears to Trigger Rejection 3 3
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Migration 3 3
Detachment of Device or Device Component 3 3
Device Contamination with Chemical or Other Material 3 3
Use of Device Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Material Rupture 1 1
Material Disintegration 1 1
Inadequate Instructions for Healthcare Professional 1 1
Material Integrity Problem 1 1
Biocompatibility 1 1
Material Split, Cut or Torn 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 233 237
Pain 124 127
No Clinical Signs, Symptoms or Conditions 47 47
Hernia 46 47
Unspecified Infection 26 26
Erosion 26 26
Fistula 23 23
Adhesion(s) 23 23
Seroma 21 21
Wound Dehiscence 16 16
Abscess 13 13
Hematoma 11 11
Impaired Healing 8 8
Obstruction/Occlusion 8 8
Dysphagia/ Odynophagia 7 7
Abdominal Pain 6 6
Bacterial Infection 6 6
Disability 6 6
Scar Tissue 6 6
Injury 6 6
Unintended Radiation Exposure 5 5
Swelling/ Edema 3 3
Fluid Discharge 3 3
Cellulitis 3 3
Inflammation 3 3
Necrosis 3 3
Drug Resistant Bacterial Infection 3 3
Diarrhea 2 2
Urinary Retention 2 2
Purulent Discharge 2 2
Abdominal Distention 2 2
Unspecified Gastrointestinal Problem 2 2
Nausea 2 2
Hemorrhage/Bleeding 2 2
Constipation 2 2
Hypersensitivity/Allergic reaction 2 2
Urinary Tract Infection 2 2
Post Traumatic Wound Infection 1 1
Fever 1 1
Rash 1 1
Localized Skin Lesion 1 1
Local Reaction 1 1
Chest Pain 1 1
Erythema 1 1
Flatus 1 1
Vomiting 1 1
Pyrosis/Heartburn 1 1
Sepsis 1 1
Stenosis 1 1
Unspecified Tissue Injury 1 1

-
-