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	9961	9961
No Apparent Adverse Event	278	278
Insufficient Information	186	186
Leak/Splash	159	159
Patient-Device Incompatibility	27	27
Off-Label Use	20	20
Use of Device Problem	16	16
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
Output Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Manufacturing, Packaging or Shipping Problem	1	1
Defective Component	1	1
Degraded	1	1
Filling Problem	1	1
Infusion or Flow Problem	1	1
No Audible Prompt/Feedback	1	1
Device Emits Odor	1	1
Detachment of Device or Device Component	1	1
Computer Software Problem	1	1
Appropriate Term/Code Not Available	1	1
Mechanical Problem	1	1
Nonstandard Device	1	1
Inadequate or Insufficient Training	1	1
Fungus in Device Environment	1	1
Insufficient Cooling	1	1
Fire	1	1
Radiofrequency Interference (RFI)	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hyperplasia	9959	9959
No Clinical Signs, Symptoms or Conditions	219	219
Insufficient Information	110	110
Hernia	64	64
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	45	45
Pain	42	42
Deformity/ Disfigurement	33	33
Physical Asymmetry	19	19
Swelling/ Edema	18	18
Partial thickness (Second Degree) Burn	16	16
Skin Discoloration	16	16
Full thickness (Third Degree) Burn	13	13
Necrosis	11	11
Unspecified Tissue Injury	10	10
Numbness	9	9
Scar Tissue	8	8
Syncope/Fainting	7	7
Depression	7	7
Hematoma	7	7
Inflammation	7	7
High Blood Pressure/ Hypertension	6	6
Neuropathy	6	6
Nerve Damage	6	6
Dizziness	6	6
Neuralgia	5	5
Pulmonary Hypertension	5	5
Anxiety	5	5
Emotional Changes	5	5
Hypersensitivity/Allergic reaction	4	4
Discomfort	3	3
Pallor	3	3
Burn(s)	3	3
Abdominal Distention	3	3
Abdominal Pain	3	3
Weight Changes	3	3
Skin Burning Sensation	2	2
Distress	2	2
Rupture	2	2
Blister	2	2
Presyncope	2	2
Paresthesia	2	2
Paralysis	2	2
Subcutaneous Nodule	2	2
Hematuria	2	2
Thrombosis/Thrombus	2	2
Unspecified Vascular Problem	2	2
Fibrosis	2	2
Urticaria	2	2
Unspecified Respiratory Problem	2	2
Dyspnea	2	2