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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device dermal cooling pack/vacuum/massager
Definition The device is a combination of a cooling pad associated with a vacuum or mechanical massager intended for the disruption or induction of adipocyte cells indicated for body contouring or reduction in circumference of body areas.
Product CodeOOK
Regulation Number 878.4340
Device Class 2


Premarket Reviews
ManufacturerDecision
ZELTIQ AESTHETICS
  SUBSTANTIALLY EQUIVALENT 1
ZELTIQ AESTHETICS, INC.
  SUBSTANTIALLY EQUIVALENT 5

MDR Year MDR Reports MDR Events
2017 9 9
2018 10 10
2019 49 49
2020 18 18
2021 1161 1161
2022 817 817

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1758 1758
Insufficient Information 208 208
No Apparent Adverse Event 74 74
Leak/Splash 49 49
Patient-Device Incompatibility 16 16
Fluid Leak 14 14
Device Displays Incorrect Message 8 8
Use of Device Problem 7 7
Device Operates Differently Than Expected 6 6
Therapeutic or Diagnostic Output Failure 6 6
Unintended Application Program Shut Down 5 5
Improper or Incorrect Procedure or Method 5 5
Material Frayed 3 3
Off-Label Use 3 3
Smoking 3 3
Application Program Problem 3 3
Device Handling Problem 2 2
Noise, Audible 2 2
Unexpected Therapeutic Results 2 2
Sparking 2 2
Loose or Intermittent Connection 1 1
Nonstandard Device 1 1
Defective Component 1 1
Radiofrequency Interference (RFI) 1 1
Fungus in Device Environment 1 1
Inadequate or Insufficient Training 1 1
Inadequate Instructions for Healthcare Professional 1 1
Insufficient Cooling 1 1
Crack 1 1
Degraded 1 1
Patient Device Interaction Problem 1 1
Physical Resistance/Sticking 1 1
Detachment of Device or Device Component 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Protective Measures Problem 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hyperplasia 1823 1823
No Clinical Signs, Symptoms or Conditions 85 85
Hernia 45 45
Pain 41 41
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 21 21
Insufficient Information 14 14
Deformity/ Disfigurement 12 12
Skin Discoloration 11 11
Swelling/ Edema 10 10
Necrosis 9 9
Partial thickness (Second Degree) Burn 8 8
Full thickness (Third Degree) Burn 8 8
Physical Asymmetry 8 8
Inflammation 7 7
Nerve Damage 6 6
Numbness 6 6
Syncope/Fainting 5 5
Depression 4 4
Swelling 4 4
Thrombosis 4 4
Hematoma 4 4
Unspecified Tissue Injury 4 4
Abdominal Pain 3 3
Tissue Damage 3 3
Hematuria 3 3
Tingling 3 3
Dizziness 3 3
Anxiety 3 3
Discomfort 3 3
Abdominal Distention 3 3
Weight Changes 3 3
Superficial (First Degree) Burn 2 2
No Known Impact Or Consequence To Patient 2 2
Neuralgia 2 2
No Code Available 2 2
Rupture 2 2
Urticaria 2 2
Scar Tissue 2 2
Thrombus 2 2
Itching Sensation 2 2
Rash 2 2
Embolism 2 2
Death 2 2
Erythema 2 2
Malaise 2 2
Pulmonary Hypertension 2 2
Unspecified Respiratory Problem 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Blister 1 1
Cryogenic Burn 1 1
Urinary Incontinence 1 1
Facial Nerve Paralysis 1 1
Fall 1 1
Hearing Impairment 1 1
Pulmonary Embolism 1 1
High Blood Pressure/ Hypertension 1 1
Hypoglycemia 1 1
Diarrhea 1 1
Dyspnea 1 1
Ecchymosis 1 1
Embolus 1 1
Emotional Changes 1 1
Arthritis 1 1
Burn(s) 1 1
Raynauds Phenomenon 1 1
Local Reaction 1 1
Loss of Range of Motion 1 1
Laceration(s) 1 1
Neuropathy 1 1
Scarring 1 1
Virus 1 1
Injury 1 1
Distress 1 1
Vascular System (Circulation), Impaired 1 1
Disability 1 1
Tooth Fracture 1 1
Neck Pain 1 1
Shaking/Tremors 1 1
Burn, Thermal 1 1
Constipation 1 1
Balance Problems 1 1
Convulsion/Seizure 1 1
Presyncope 1 1
Paresthesia 1 1
Thrombosis/Thrombus 1 1
Unspecified Vascular Problem 1 1
Fibrosis 1 1
Test Result 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Zeltiq Aesthetics, Inc II Aug-27-2021
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