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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device elastomer, silicone block
Product CodeMIB
Regulation Number 874.3620
Device Class 2


Premarket Reviews
ManufacturerDecision
BISTOOL
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 3
METALWARE TECHNOLOGY CORP.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1 1
2018 10 10
2019 3 3
2020 1 1
2021 5 5
2022 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 9 9
Migration or Expulsion of Device 4 4
Product Quality Problem 4 4
Device Appears to Trigger Rejection 4 4
Patient Device Interaction Problem 3 3
Inadequacy of Device Shape and/or Size 2 2
Use of Device Problem 2 2
Insufficient Information 2 2
Break 2 2
Patient-Device Incompatibility 2 2
Improper or Incorrect Procedure or Method 1 1
Device Damaged Prior to Use 1 1
Migration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 10 10
Failure of Implant 7 7
Deformity/ Disfigurement 7 7
Post Operative Wound Infection 4 4
No Code Available 3 3
Bacterial Infection 3 3
Seroma 3 3
Scar Tissue 2 2
Capsular Contracture 2 2
Decreased Sensitivity 2 2
Fluid Discharge 2 2
Erectile Dysfunction 2 2
Drug Resistant Bacterial Infection 2 2
Asthma 1 1
Patient Problem/Medical Problem 1 1
Multiple Organ Failure 1 1
Sexual Dysfunction 1 1
Numbness 1 1
Cellulitis 1 1
Edema 1 1
Emotional Changes 1 1
Erosion 1 1
Inflammation 1 1
Nerve Damage 1 1
Sepsis 1 1
Perforation 1 1
Swelling 1 1
Tachycardia 1 1
Tissue Damage 1 1
Immunodeficiency 1 1
No Consequences Or Impact To Patient 1 1
Anaphylactoid 1 1

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