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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 19 19

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
Off-Label Use 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Device Appears to Trigger Rejection 5 5
Patient-Device Incompatibility 5 5
Difficult to Open or Remove Packaging Material 5 5
Device Contamination with Chemical or Other Material 4 4
Defective Device 4 4
Gel Leak 3 3
Material Puncture/Hole 2 2
Device Reprocessing Problem 2 2
Deflation Problem 2 2
Material Disintegration 2 2
Device Contaminated During Manufacture or Shipping 2 2
Device Markings/Labelling Problem 2 2
Packaging Problem 2 2
Appropriate Term/Code Not Available 1 1
Output Problem 1 1
Patient Device Interaction Problem 1 1
Inaccurate Information 1 1
Use of Device Problem 1 1
Entrapment of Device 1 1
Fluid/Blood Leak 1 1
Material Discolored 1 1
Contamination 1 1
Burst Container or Vessel 1 1
Nonstandard Device 1 1
Unsealed Device Packaging 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Microbial Contamination of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 46 46
No Clinical Signs, Symptoms or Conditions 30 30
Capsular Contracture 13 13
Insufficient Information 11 11
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
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
Ptosis 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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