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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, plastic and reconstructive surgery
Definition For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery.
Product CodeOXF
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
PRINTBIO, INC.
  SUBSTANTIALLY EQUIVALENT 1
W. L. GORE AND ASSOCIATES, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 1 1
2021 7 7
2022 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Microbial Contamination of Device 2 2
Material Separation 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Seroma 6 6
Unspecified Infection 2 2
Hematoma 2 2
Numbness 2 2
Pain 2 2
Abscess 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Skin Inflammation/ Irritation 1 1
Itching Sensation 1 1
Local Reaction 1 1
Rash 1 1
Chest Pain 1 1
Erythema 1 1
Swelling 1 1
Anxiety 1 1
Irritability 1 1

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