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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, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2019 49 49
2020 18 18
2021 1161 1161
2022 1978 1978
2023 5499 5499
2024 367 367

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8679 8679
No Apparent Adverse Event 208 208
Insufficient Information 207 207
Leak/Splash 109 109
Patient-Device Incompatibility 26 26
Fluid/Blood Leak 14 14
Use of Device Problem 11 11
Therapeutic or Diagnostic Output Failure 9 9
Device Displays Incorrect Message 8 8
Off-Label Use 8 8
Sparking 6 6
Unintended Application Program Shut Down 5 5
Smoking 4 4
Unexpected Therapeutic Results 4 4
Improper or Incorrect Procedure or Method 4 4
Material Frayed 3 3
Application Program Problem 3 3
Temperature Problem 3 3
Device Handling Problem 3 3
Noise, Audible 3 3
Output Problem 2 2
Crack 2 2
Unexpected Shutdown 2 2
Degraded 1 1
Filling Problem 1 1
Break 1 1
Insufficient Cooling 1 1
Mechanical Problem 1 1
Nonstandard Device 1 1
Device Emits Odor 1 1
No Audible Prompt/Feedback 1 1
Defective Component 1 1
Radiofrequency Interference (RFI) 1 1
Fungus in Device Environment 1 1
Inadequate or Insufficient Training 1 1
Patient Device Interaction Problem 1 1
Detachment of Device or Device Component 1 1
Infusion or Flow Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hyperplasia 8719 8719
No Clinical Signs, Symptoms or Conditions 162 162
Insufficient Information 109 109
Hernia 72 72
Pain 40 40
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 39 39
Deformity/ Disfigurement 25 25
Swelling/ Edema 17 17
Necrosis 15 15
Full thickness (Third Degree) Burn 14 14
Skin Discoloration 13 13
Physical Asymmetry 13 13
Partial thickness (Second Degree) Burn 10 10
Unspecified Tissue Injury 9 9
Nerve Damage 9 9
Neuropathy 7 7
Inflammation 7 7
Syncope/Fainting 7 7
Numbness 7 7
Scar Tissue 7 7
Hematoma 6 6
Emotional Changes 5 5
High Blood Pressure/ Hypertension 5 5
Dizziness 5 5
Anxiety 5 5
Depression 5 5
Abdominal Distention 4 4
Neuralgia 4 4
Swelling 4 4
Pulmonary Hypertension 4 4
Tingling 3 3
Thrombosis 3 3
Itching Sensation 3 3
Abdominal Pain 3 3
Weight Changes 3 3
Hematuria 3 3
Superficial (First Degree) Burn 2 2
No Known Impact Or Consequence To Patient 2 2
Fibrosis 2 2
Discomfort 2 2
Pallor 2 2
Urticaria 2 2
Rupture 2 2
Dyspnea 2 2
Embolism 2 2
Erythema 2 2
Rash 2 2
Thrombosis/Thrombus 2 2
Unspecified Respiratory Problem 2 2
Subcutaneous Nodule 2 2
Nodule 1 1
Urinary Incontinence 1 1
Unspecified Gastrointestinal Problem 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Blister 1 1
Cryogenic Burn 1 1
Skin Infection 1 1
Unspecified Vascular Problem 1 1
Local Reaction 1 1
Paralysis 1 1
Loss of Range of Motion 1 1
Thrombus 1 1
Tissue Damage 1 1
Virus 1 1
Burning Sensation 1 1
Laceration(s) 1 1
Nausea 1 1
Hypoglycemia 1 1
Unspecified Infection 1 1
Facial Nerve Paralysis 1 1
Fall 1 1
Hearing Impairment 1 1
Hyperemia 1 1
Hypersensitivity/Allergic reaction 1 1
Embolus 1 1
Ecchymosis 1 1
Arrhythmia 1 1
Autoimmune Disorder 1 1
Burn(s) 1 1
Chest Pain 1 1
Death 1 1
Diarrhea 1 1
Pulmonary Embolism 1 1
Distress 1 1
Shaking/Tremors 1 1
Burn, Thermal 1 1
Ambulation Difficulties 1 1
Electric Shock 1 1
Malaise 1 1
Disability 1 1
No Code Available 1 1
Constipation 1 1
Balance Problems 1 1
Convulsion/Seizure 1 1
Presyncope 1 1
Peripheral Nervous Injury 1 1
Paresthesia 1 1
Suicidal Ideation 1 1
Tissue Breakdown 1 1
Vascular System (Circulation), Impaired 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Zeltiq Aesthetics, Inc II Jul-11-2022
2 Zeltiq Aesthetics, Inc II Aug-27-2021
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