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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 1
MOTIVA USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
SIENTRA, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 14 14
2020 11 11
2021 20 20
2022 31 31
2023 31 31
2024 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 37 37
Device Handling Problem 21 21
Break 12 12
Improper or Incorrect Procedure or Method 7 7
Device Appears to Trigger Rejection 6 6
Off-Label Use 5 5
Difficult to Open or Remove Packaging Material 5 5
Patient-Device Incompatibility 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Defective Device 4 4
Device Contamination with Chemical or Other Material 4 4
Gel Leak 3 3
Inaccurate Information 3 3
Device Contaminated During Manufacture or Shipping 2 2
Device Markings/Labelling Problem 2 2
Material Disintegration 2 2
Material Puncture/Hole 2 2
Deflation Problem 2 2
Packaging Problem 2 2
Device Reprocessing Problem 2 2
Burst Container or Vessel 1 1
Entrapment of Device 1 1
Output Problem 1 1
Device Damaged Prior to Use 1 1
Unsealed Device Packaging 1 1
Defective Component 1 1
Contamination 1 1
Microbial Contamination of Device 1 1
Patient Device Interaction Problem 1 1
Material Discolored 1 1
Use of Device 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 49 49
No Clinical Signs, Symptoms or Conditions 32 32
Capsular Contracture 14 14
Insufficient Information 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Pain 4 4
Unspecified Infection 3 3
No Code Available 3 3
No Consequences Or Impact To Patient 3 3
Fatigue 2 2
Nausea 2 2
Post Operative Wound Infection 2 2
Seroma 2 2
No Patient Involvement 2 2
Headache 2 2
Extreme Exhaustion 1 1
Wound Dehiscence 1 1
Respiratory Distress 1 1
Not Applicable 1 1
Necrosis 1 1
Dizziness 1 1
No Information 1 1
Inflammation 1 1
Purulent Discharge 1 1
Gastritis 1 1
Autoimmune Disorder 1 1
Foreign Body Reaction 1 1
Rash 1 1
Injury 1 1
Ptosis 1 1
Foreign Body In Patient 1 1
Swelling 1 1
Dyspnea 1 1
Visual Impairment 1 1
Deformity/ Disfigurement 1 1
Granuloma 1 1
Ambulation Difficulties 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Allergan PLC III Dec-18-2019
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