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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
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOVUS SCIENTIFIC AB
  SUBSTANTIALLY EQUIVALENT 1
W.L. GORE & ASSOCIATES, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 31 31
2019 61 61
2020 44 44
2021 58 58
2022 103 103
2023 55 55

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Device 198 198
Patient Device Interaction Problem 183 183
Insufficient Information 116 116
Patient-Device Incompatibility 32 32
Adverse Event Without Identified Device or Use Problem 6 6
Expiration Date Error 3 3
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Material Separation 2 2
Device Appears to Trigger Rejection 2 2
Material Deformation 2 2
Material Protrusion/Extrusion 1 1
Biocompatibility 1 1
Device Operates Differently Than Expected 1 1
Device Contamination with Chemical or Other Material 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Material Too Rigid or Stiff 1 1
Contamination 1 1
Material Disintegration 1 1
Hole In Material 1 1
Inadequate Instructions for Healthcare Professional 1 1
Migration or Expulsion of Device 1 1
Torn Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 161 161
Pain 137 137
Hernia 59 59
No Clinical Signs, Symptoms or Conditions 41 41
Injury 37 37
Unspecified Infection 28 28
Fistula 22 22
Disability 22 22
Seroma 20 20
Adhesion(s) 17 17
No Code Available 14 14
Abdominal Pain 10 10
Wound Dehiscence 9 9
Obstruction/Occlusion 8 8
Impaired Healing 7 7
Abscess 7 7
Erosion 6 6
No Information 5 5
Hematoma 4 4
Dysphagia/ Odynophagia 3 3
Cellulitis 3 3
Bacterial Infection 3 3
Diarrhea 2 2
Discomfort 2 2
Scar Tissue 2 2
Inflammation 2 2
Rash 2 2
Swelling/ Edema 2 2
Constipation 2 2
Abdominal Distention 2 2
Weight Changes 1 1
Thromboembolism 1 1
Bowel Perforation 1 1
Fluid Discharge 1 1
Reaction 1 1
Deformity/ Disfigurement 1 1
Unspecified Gastrointestinal Problem 1 1
Localized Skin Lesion 1 1
Subcutaneous Nodule 1 1
Drug Resistant Bacterial Infection 1 1
Local Reaction 1 1
Perforation 1 1
Muscle Spasm(s) 1 1
Nausea 1 1
Sepsis 1 1
Skin Discoloration 1 1
Swelling 1 1
Cramp(s) 1 1
No Consequences Or Impact To Patient 1 1
Discharge 1 1
Erythema 1 1
Flatus 1 1
Foreign Body Reaction 1 1
Granuloma 1 1
Pyrosis/Heartburn 1 1
Death 1 1
Pulmonary Embolism 1 1

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