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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Device 218 218
Patient Device Interaction Problem 204 204
Insufficient Information 90 90
Patient-Device Incompatibility 36 36
Adverse Event Without Identified Device or Use Problem 4 4
Expiration Date Error 4 4
Improper or Incorrect Procedure or Method 2 2
Device Appears to Trigger Rejection 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Material Separation 2 2
Device Contamination with Chemical or Other Material 2 2
Material Deformation 1 1
Material Protrusion/Extrusion 1 1
Biocompatibility 1 1
Migration 1 1
Use of Device Problem 1 1
Contamination 1 1
Material Disintegration 1 1
Inadequate Instructions for Healthcare Professional 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 182 182
Pain 141 141
No Clinical Signs, Symptoms or Conditions 44 44
Hernia 40 40
Injury 36 36
Unspecified Infection 27 27
Disability 21 21
Fistula 21 21
Adhesion(s) 16 16
Seroma 15 15
No Code Available 14 14
Wound Dehiscence 8 8
Abscess 8 8
Impaired Healing 7 7
Obstruction/Occlusion 7 7
Erosion 6 6
Abdominal Pain 5 5
Bacterial Infection 4 4
Hematoma 4 4
No Information 4 4
Cellulitis 3 3
Diarrhea 2 2
Dysphagia/ Odynophagia 2 2
Inflammation 2 2
Rash 2 2
Scar Tissue 2 2
Drug Resistant Bacterial Infection 2 2
Swelling/ Edema 2 2
Abdominal Distention 2 2
Thromboembolism 1 1
Bowel Perforation 1 1
Fluid Discharge 1 1
Constipation 1 1
Unspecified Gastrointestinal Problem 1 1
Localized Skin Lesion 1 1
Subcutaneous Nodule 1 1
Sepsis 1 1
Local Reaction 1 1
Nausea 1 1
Perforation 1 1
Reaction 1 1
Deformity/ Disfigurement 1 1
No Consequences Or Impact To Patient 1 1
Discharge 1 1
Discomfort 1 1
Erythema 1 1
Failure of Implant 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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