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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Device 229 232
Patient Device Interaction Problem 223 226
Patient-Device Incompatibility 90 91
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
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Device Contamination with Chemical or Other Material 3 3
Device Appears to Trigger Rejection 3 3
Use of Device Problem 2 2
Detachment of Device or Device Component 2 2
Migration 2 2
Improper or Incorrect Procedure or Method 2 2
Material Split, Cut or Torn 1 1
Material Disintegration 1 1
Inadequate Instructions for Healthcare Professional 1 1
Material Rupture 1 1
Appropriate Term/Code Not Available 1 1
Biocompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 232 236
Pain 124 127
No Clinical Signs, Symptoms or Conditions 44 44
Hernia 42 43
Unspecified Infection 26 26
Fistula 20 20
Adhesion(s) 19 19
Seroma 19 19
Wound Dehiscence 15 15
Abscess 13 13
Hematoma 11 11
Dysphagia/ Odynophagia 7 7
Erosion 7 7
Impaired Healing 7 7
Obstruction/Occlusion 7 7
Abdominal Pain 6 6
Bacterial Infection 6 6
Injury 6 6
Disability 6 6
Scar Tissue 5 5
Unintended Radiation Exposure 5 5
Swelling/ Edema 3 3
Fluid Discharge 3 3
Inflammation 3 3
Cellulitis 3 3
Diarrhea 2 2
Purulent Discharge 2 2
Hemorrhage/Bleeding 2 2
Hypersensitivity/Allergic reaction 2 2
Nausea 2 2
Necrosis 2 2
Urinary Retention 2 2
Urinary Tract Infection 2 2
Drug Resistant Bacterial Infection 2 2
Abdominal Distention 2 2
Constipation 2 2
Unspecified Gastrointestinal Problem 2 2
Localized Skin Lesion 1 1
Subcutaneous Nodule 1 1
Tissue Breakdown 1 1
Post Traumatic Wound Infection 1 1
Unspecified Tissue Injury 1 1
Fibrosis 1 1
Vomiting 1 1
Stenosis 1 1
Urticaria 1 1
Sepsis 1 1
Rash 1 1
Local Reaction 1 1
Failure of Implant 1 1

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