TPLC - Total Product Life Cycle

• 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 Code: OOK
• Regulation Number: 878.4340
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
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