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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 48 48

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Device 243 243
Patient Device Interaction Problem 229 229
Insufficient Information 90 90
Patient-Device Incompatibility 47 47
Adverse Event Without Identified Device or Use Problem 4 4
Expiration Date Error 4 4
Device Contamination with Chemical or Other Material 3 3
Improper or Incorrect Procedure or Method 2 2
Material Separation 2 2
Device Appears to Trigger Rejection 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Material Rupture 1 1
Contamination 1 1
Material Disintegration 1 1
Inadequate Instructions for Healthcare Professional 1 1
Use of Device Problem 1 1
Material Deformation 1 1
Material Protrusion/Extrusion 1 1
Biocompatibility 1 1
Migration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 207 207
Pain 142 142
Hernia 45 45
No Clinical Signs, Symptoms or Conditions 45 45
Injury 36 36
Unspecified Infection 31 31
Fistula 25 25
Disability 21 21
Seroma 18 18
Adhesion(s) 17 17
No Code Available 14 14
Wound Dehiscence 10 10
Erosion 9 9
Abscess 8 8
Hematoma 7 7
Impaired Healing 7 7
Obstruction/Occlusion 7 7
Abdominal Pain 5 5
Bacterial Infection 4 4
Dysphagia/ Odynophagia 4 4
No Information 4 4
Cellulitis 3 3
Inflammation 3 3
Rash 2 2
Scar Tissue 2 2
Urinary Retention 2 2
Urinary Tract Infection 2 2
Abdominal Distention 2 2
Diarrhea 2 2
Fluid Discharge 2 2
Drug Resistant Bacterial Infection 2 2
Swelling/ Edema 2 2
Constipation 1 1
Unspecified Gastrointestinal Problem 1 1
Localized Skin Lesion 1 1
Subcutaneous Nodule 1 1
Reaction 1 1
Thromboembolism 1 1
Bowel Perforation 1 1
No Consequences Or Impact To Patient 1 1
Discharge 1 1
Deformity/ Disfigurement 1 1
Discomfort 1 1
Sepsis 1 1
Local Reaction 1 1
Nausea 1 1
Perforation 1 1
Death 1 1
Pulmonary Embolism 1 1
Erythema 1 1
Fever 1 1
Failure of Implant 1 1
Flatus 1 1
Foreign Body Reaction 1 1
Granuloma 1 1
Pyrosis/Heartburn 1 1

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