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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device elastomer, silicone block
Product CodeMIB
Regulation Number 874.3620
Device Class 2


Premarket Reviews
ManufacturerDecision
AUGMENTA LLC
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 3
KEOSAN TRADING CO.
  SUBSTANTIALLY EQUIVALENT 1
METALWARE TECHNOLOGY CORP.
  SUBSTANTIALLY EQUIVALENT 1
SHINEO TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 3 3
2020 1 1
2021 5 5
2022 19 19
2023 74 74
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 30 30
Insufficient Information 20 20
Use of Device Problem 14 14
Migration or Expulsion of Device 11 11
Patient Device Interaction Problem 9 9
Product Quality Problem 6 6
Device Appears to Trigger Rejection 4 4
Malposition of Device 4 4
Inadequacy of Device Shape and/or Size 4 4
Break 3 3
Patient-Device Incompatibility 3 3
Material Protrusion/Extrusion 3 3
No Apparent Adverse Event 3 3
Use of Incorrect Control/Treatment Settings 2 2
Material Fragmentation 2 2
Improper or Incorrect Procedure or Method 2 2
Material Integrity Problem 1 1
Positioning Problem 1 1
Fracture 1 1
Microbial Contamination of Device 1 1
Difficult to Insert 1 1
Migration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 29 29
Deformity/ Disfigurement 25 25
Swelling/ Edema 25 25
Failure of Implant 20 20
Seroma 18 18
Decreased Sensitivity 17 17
Erosion 16 16
Scar Tissue 15 15
Implant Pain 10 10
Sexual Dysfunction 8 8
Depression 8 8
Inflammation 8 8
Post Operative Wound Infection 8 8
Unspecified Infection 6 6
Numbness 6 6
Nerve Damage 6 6
Erectile Dysfunction 6 6
Insufficient Information 5 5
Bacterial Infection 4 4
Emotional Changes 4 4
Skin Erosion 3 3
Fluid Discharge 3 3
Wrinkling 3 3
Wound Dehiscence 3 3
Perforation 2 2
Hematoma 2 2
Skin Inflammation/ Irritation 2 2
Dysuria 2 2
Capsular Contracture 2 2
Unspecified Tissue Injury 2 2
Drug Resistant Bacterial Infection 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Blister 1 1
Cellulitis 1 1
Foreign Body Reaction 1 1
Anaphylactoid 1 1
Edema 1 1
Asthma 1 1
Discomfort 1 1
Adhesion(s) 1 1
Fungal Infection 1 1
Tachycardia 1 1
Sepsis 1 1
Tissue Damage 1 1
Immunodeficiency 1 1
Unspecified Vascular Problem 1 1

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