TPLC - Total Product Life Cycle

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Device	dermal cooling pack/vacuum/massager
Regulation Description	Contact cooling system for aesthetic use.
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, INC.
	SUBSTANTIALLY EQUIVALENT	2
ZELTIQ AESTHETICS, INC. (ACQUIRED BY ALLERGAN AESTHETICS
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	10374	10375
No Apparent Adverse Event	282	282
Insufficient Information	186	186
Leak/Splash	166	166
Patient-Device Incompatibility	27	29
Off-Label Use	21	21
Use of Device Problem	18	18
Fluid/Blood Leak	14	14
Device Displays Incorrect Message	8	8
Therapeutic or Diagnostic Output Failure	8	8
Sparking	6	6
Temperature Problem	5	5
Unintended Application Program Shut Down	5	5
Unexpected Therapeutic Results	4	4
Device Handling Problem	4	4
Smoking	4	4
Noise, Audible	3	3
Material Integrity Problem	3	3
Application Program Problem	3	3
Break	3	3
Unexpected Shutdown	3	3
Material Frayed	3	3
Patient Device Interaction Problem	2	2
Crack	2	2
Appropriate Term/Code Not Available	2	2
Improper or Incorrect Procedure or Method	2	2
Output Problem	2	2
Defective Component	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Degraded	1	1
Filling Problem	1	1
Infusion or Flow Problem	1	1
No Audible Prompt/Feedback	1	1
Mechanical Problem	1	1
Device Emits Odor	1	1
Detachment of Device or Device Component	1	1
Computer Software Problem	1	1
Nonstandard Device	1	2
Fire	1	1
Inadequate or Insufficient Training	1	1
Fungus in Device Environment	1	1
Insufficient Cooling	1	1
Radiofrequency Interference (RFI)	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hyperplasia	10357	10357
No Clinical Signs, Symptoms or Conditions	227	227
Insufficient Information	113	113
Hernia	65	65
Pain	48	51
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	47	50
Deformity/ Disfigurement	34	35
Physical Asymmetry	21	21
Partial thickness (Second Degree) Burn	18	18
Swelling/ Edema	18	18
Skin Discoloration	17	17
Necrosis	16	16
Full thickness (Third Degree) Burn	13	13
Scar Tissue	11	11
Unspecified Tissue Injury	10	10
Numbness	9	9
Inflammation	9	9
Hematoma	8	8
Depression	7	7
Syncope/Fainting	7	7
Neuropathy	6	6
High Blood Pressure/ Hypertension	6	6
Pulmonary Hypertension	6	6
Nerve Damage	6	7
Dizziness	6	6
Anxiety	5	5
Neuralgia	5	5
Emotional Changes	5	5
Abdominal Pain	5	5
Hypersensitivity/Allergic reaction	4	4
Discomfort	3	3
Pallor	3	3
Abdominal Distention	3	3
Burn(s)	3	3
Blister	3	3
Weight Changes	3	4
Peripheral Nervous Injury	2	2
Paralysis	2	2
Thrombosis/Thrombus	2	2
Dyspnea	2	2
Paresthesia	2	2
Unspecified Respiratory Problem	2	2
Rupture	2	2
Unspecified Vascular Problem	2	2
Fibrosis	2	2
Presyncope	2	2
Hematuria	2	2
Subcutaneous Nodule	2	2
Distress	2	2
Urticaria	2	2