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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
SIENTRA, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 11 11
2021 20 21
2022 31 37
2023 30 33
2024 37 37
2025 46 46

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 40 46
Device Handling Problem 30 31
Difficult to Open or Remove Packaging Material 28 28
Break 16 16
Adverse Event Without Identified Device or Use Problem 7 9
Device Appears to Trigger Rejection 7 7
Improper or Incorrect Procedure or Method 6 6
Device Contamination with Chemical or Other Material 5 5
Defective Device 4 4
Device Contaminated During Manufacture or Shipping 3 3
Patient-Device Incompatibility 3 4
Use of Device Problem 3 3
Packaging Problem 3 3
Inaccurate Information 3 3
Off-Label Use 2 3
Device Markings/Labelling Problem 2 2
Material Disintegration 2 2
Material Puncture/Hole 2 2
Unsealed Device Packaging 2 2
Deflation Problem 2 3
Material Discolored 2 2
Device Reprocessing Problem 2 2
Gel Leak 2 2
Burst Container or Vessel 1 1
Output Problem 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Contamination 1 1
Microbial Contamination of Device 1 1
Patient Device Interaction Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
No Apparent Adverse Event 1 1
Appropriate Term/Code Not Available 1 1
Nonstandard Device 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 65 67
No Clinical Signs, Symptoms or Conditions 63 65
Insufficient Information 16 18
Capsular Contracture 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 8
Unspecified Infection 3 4
Pain 3 4
No Consequences Or Impact To Patient 3 3
Nausea 2 2
Post Operative Wound Infection 2 2
Deformity/ Disfigurement 2 3
Headache 2 2
Wound Dehiscence 1 1
Fatigue 1 2
Necrosis 1 2
Gastritis 1 2
Purulent Discharge 1 1
Foreign Body Reaction 1 1
Rash 1 2
Seroma 1 2
Ptosis 1 1
No Patient Involvement 1 1
Dyspnea 1 2
Granuloma 1 1

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