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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
Definition For reinforcement of soft tissue where weakness exists during hernia repair.
Product CodeOWT
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOREZ, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOVUS SCIENTIFIC AB
  SUBSTANTIALLY EQUIVALENT 1
SOFRADIM PRODUCTION
  SUBSTANTIALLY EQUIVALENT 1
W.L. GORE & ASSOCIATES, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 61 61
2020 44 44
2021 58 58
2022 103 103
2023 75 75
2024 60 60

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Device 249 249
Patient Device Interaction Problem 235 235
Insufficient Information 90 90
Patient-Device Incompatibility 49 49
Expiration Date Error 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Material Separation 3 3
Device Contamination with Chemical or Other Material 3 3
Device Appears to Trigger Rejection 3 3
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Improper or Incorrect Procedure or Method 2 2
Material Disintegration 1 1
Contamination 1 1
Inadequate Instructions for Healthcare Professional 1 1
Use of Device Problem 1 1
Material Rupture 1 1
Material Deformation 1 1
Tear, Rip or Hole in Device Packaging 1 1
Material Protrusion/Extrusion 1 1
Migration 1 1
Biocompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 215 215
Pain 142 142
No Clinical Signs, Symptoms or Conditions 47 47
Hernia 46 46
Injury 36 36
Unspecified Infection 32 32
Fistula 25 25
Disability 21 21
Seroma 18 18
Adhesion(s) 17 17
No Code Available 14 14
Wound Dehiscence 10 10
Erosion 10 10
Abscess 8 8
Impaired Healing 7 7
Hematoma 7 7
Obstruction/Occlusion 7 7
Abdominal Pain 5 5
No Information 4 4
Dysphagia/ Odynophagia 4 4
Bacterial Infection 4 4
Inflammation 3 3
Cellulitis 3 3
Fluid Discharge 2 2
Scar Tissue 2 2
Urinary Retention 2 2
Swelling/ Edema 2 2
Diarrhea 2 2
Rash 2 2
Abdominal Distention 2 2
Drug Resistant Bacterial Infection 2 2
Urinary Tract Infection 2 2
Discharge 1 1
Physical Asymmetry 1 1
No Consequences Or Impact To Patient 1 1
Deformity/ Disfigurement 1 1
Thromboembolism 1 1
Constipation 1 1
Capsular Contracture 1 1
Subcutaneous Nodule 1 1
Granuloma 1 1
Pulmonary Embolism 1 1
Reaction 1 1
Discomfort 1 1
Flatus 1 1
Erythema 1 1
Fever 1 1
Foreign Body Reaction 1 1
Localized Skin Lesion 1 1
Local Reaction 1 1

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