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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mammary sizer
Product CodeMRD
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
ALLERGAN
  SUBSTANTIALLY EQUIVALENT 1
MENTOR WORLDWIDE, LLC
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 20 21
2022 31 37
2023 30 33
2024 37 37
2025 48 48
2026 24 24

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Open or Remove Packaging Material 33 33
Device Handling Problem 30 31
Material Rupture 29 33
Break 16 16
Contamination 10 10
Device Contamination with Chemical or Other Material 9 9
Device Appears to Trigger Rejection 9 9
Adverse Event Without Identified Device or Use Problem 6 7
Use of Device Problem 5 5
Device Contaminated During Manufacture or Shipping 4 4
Improper or Incorrect Procedure or Method 4 4
Packaging Problem 3 3
Device Reprocessing Problem 3 3
Inaccurate Information 3 3
Off-Label Use 2 3
Material Disintegration 2 2
Unsealed Device Packaging 2 2
Burst Container or Vessel 1 1
Incomplete or Missing Packaging 1 1
Device Damaged Prior to Use 1 1
Patient-Device Incompatibility 1 1
Deflation Problem 1 2
Microbial Contamination of Device 1 1
Delivered as Unsterile Product 1 1
Labelling, Instructions for Use or Training Problem 1 1
No Apparent Adverse Event 1 1
Gel Leak 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 84 86
Failure of Implant 66 68
Insufficient Information 16 18
Capsular Contracture 12 12
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 7 8
Unspecified Infection 3 4
Pain 3 4
Nausea 2 2
Post Operative Wound Infection 2 2
Headache 2 2
Deformity/ Disfigurement 2 3
Wound Dehiscence 1 1
Fatigue 1 2
Necrosis 1 2
Purulent Discharge 1 1
Gastritis 1 2
Foreign Body Reaction 1 1
Rash 1 2
Seroma 1 2
Ptosis 1 1
Dyspnea 1 2
Granuloma 1 1

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