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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
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 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 36 36
Device Handling Problem 21 21
Break 12 12
Improper or Incorrect Procedure or Method 7 7
Device Appears to Trigger Rejection 5 5
Patient-Device Incompatibility 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Off-Label Use 5 5
Defective Device 4 4
Gel Leak 3 3
Difficult to Open or Remove Packaging Material 2 2
Packaging Problem 2 2
Device Markings/Labelling Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Device Contamination with Chemical or Other Material 2 2
Material Puncture/Hole 2 2
Deflation Problem 2 2
Material Disintegration 2 2
Device Reprocessing Problem 2 2
Burst Container or Vessel 1 1
Contamination 1 1
Defective Component 1 1
Material Discolored 1 1
Use of Device Problem 1 1
Appropriate Term/Code Not Available 1 1
Unsealed Device Packaging 1 1
Patient Device Interaction Problem 1 1
Entrapment of Device 1 1
Device Damaged Prior to Use 1 1
Microbial Contamination of Device 1 1
Nonstandard Device 1 1
Output Problem 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 43 43
No Clinical Signs, Symptoms or Conditions 27 27
Capsular Contracture 12 12
Insufficient Information 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Pain 4 4
Unspecified Infection 3 3
No Code Available 3 3
No Consequences Or Impact To Patient 3 3
Post Operative Wound Infection 2 2
Seroma 2 2
Headache 2 2
No Patient Involvement 2 2
Nausea 2 2
Fatigue 2 2
Foreign Body Reaction 1 1
Gastritis 1 1
Granuloma 1 1
Purulent Discharge 1 1
Dyspnea 1 1
Extreme Exhaustion 1 1
Necrosis 1 1
Rash 1 1
Respiratory Distress 1 1
Inflammation 1 1
Wound Dehiscence 1 1
Autoimmune Disorder 1 1
Foreign Body In Patient 1 1
Not Applicable 1 1
No Information 1 1
Swelling 1 1
Visual Impairment 1 1
Dizziness 1 1
Ambulation Difficulties 1 1
Injury 1 1
Deformity/ Disfigurement 1 1

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