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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
2017 8 8
2018 11 11
2019 14 14
2020 11 11
2021 20 20
2022 31 31
2023 31 31
2024 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 36 36
Device Handling Problem 21 21
Break 17 17
Improper or Incorrect Procedure or Method 10 10
Device Contamination with Chemical or Other Material 9 9
Adverse Event Without Identified Device or Use Problem 6 6
Device Appears to Trigger Rejection 5 5
Patient-Device Incompatibility 5 5
Off-Label Use 5 5
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 Markings/Labelling Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Packaging Problem 2 2
Difficult to Open or Remove Packaging Material 2 2
Positioning Problem 1 1
Appropriate Term/Code Not Available 1 1
Patient Device Interaction Problem 1 1
Material Deformation 1 1
Output Problem 1 1
Device Operates Differently Than Expected 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Microbial Contamination of Device 1 1
Residue After Decontamination 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
Use of Device Problem 1 1
Hole In Material 1 1
Leak/Splash 1 1
Nonstandard Device 1 1
Unsealed Device Packaging 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 13 13
No Known Impact Or Consequence To Patient 12 12
Insufficient Information 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Pain 5 5
No Consequences Or Impact To Patient 4 4
No Code Available 4 4
No Information 3 3
Unspecified Infection 3 3
Fatigue 2 2
Headache 2 2
Not Applicable 2 2
Post Operative Wound Infection 2 2
No Patient Involvement 2 2
Nausea 2 2
Seroma 2 2
Swelling 1 1
Visual Impairment 1 1
Dizziness 1 1
Necrosis 1 1
Injury 1 1
Deformity/ Disfigurement 1 1
Foreign Body In Patient 1 1
Ambulation Difficulties 1 1
Foreign Body Reaction 1 1
Gastritis 1 1
Granuloma 1 1
Purulent Discharge 1 1
Dyspnea 1 1
Extreme Exhaustion 1 1
Inflammation 1 1
Wound Dehiscence 1 1
Autoimmune Disorder 1 1
Loss of Range of Motion 1 1
Rash 1 1
Respiratory Distress 1 1

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