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	9613	9613
No Apparent Adverse Event	262	262
Insufficient Information	186	186
Leak/Splash	142	142
Patient-Device Incompatibility	26	26
Off-Label Use	16	16
Fluid/Blood Leak	14	14
Use of Device Problem	11	11
Device Displays Incorrect Message	8	8
Therapeutic or Diagnostic Output Failure	8	8
Sparking	6	6
Unintended Application Program Shut Down	5	5
Temperature Problem	4	4
Unexpected Therapeutic Results	4	4
Smoking	4	4
Device Handling Problem	3	3
Material Frayed	3	3
Material Integrity Problem	3	3
Break	3	3
Application Program Problem	3	3
Noise, Audible	3	3
Improper or Incorrect Procedure or Method	2	2
Crack	2	2
Unexpected Shutdown	2	2
Output Problem	2	2
Defective Component	1	1
Insufficient Cooling	1	1
Inadequate or Insufficient Training	1	1
Nonstandard Device	1	1
Patient Device Interaction Problem	1	1
No Audible Prompt/Feedback	1	1
Radiofrequency Interference (RFI)	1	1
Degraded	1	1
Infusion or Flow Problem	1	1
Fungus in Device Environment	1	1
Fire	1	1
Appropriate Term/Code Not Available	1	1
Device Emits Odor	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Filling Problem	1	1
Computer Software Problem	1	1
Detachment of Device or Device Component	1	1
Mechanical Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hyperplasia	9646	9646
No Clinical Signs, Symptoms or Conditions	204	204
Insufficient Information	109	109
Hernia	60	60
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	43	43
Pain	40	40
Deformity/ Disfigurement	31	31
Swelling/ Edema	17	17
Physical Asymmetry	17	17
Skin Discoloration	14	14
Partial thickness (Second Degree) Burn	13	13
Full thickness (Third Degree) Burn	12	12
Necrosis	10	10
Unspecified Tissue Injury	10	10
Numbness	7	7
Inflammation	7	7
Scar Tissue	7	7
Syncope/Fainting	7	7
Hematoma	7	7
Neuropathy	6	6
Dizziness	6	6
Nerve Damage	6	6
Depression	6	6
Pulmonary Hypertension	5	5
Emotional Changes	5	5
Anxiety	5	5
High Blood Pressure/ Hypertension	5	5
Neuralgia	4	4
Abdominal Distention	3	3
Abdominal Pain	3	3
Burn(s)	3	3
Weight Changes	3	3
Blister	2	2
Thrombosis/Thrombus	2	2
Hematuria	2	2
Skin Burning Sensation	2	2
Fibrosis	2	2
Hypersensitivity/Allergic reaction	2	2
Subcutaneous Nodule	2	2
Dyspnea	2	2
Urticaria	2	2
Pallor	2	2
Rupture	2	2
Distress	2	2
Unspecified Respiratory Problem	2	2
Discomfort	2	2
Paresthesia	2	2
Superficial (First Degree) Burn	2	2
Unspecified Vascular Problem	2	2
Gastrointestinal Hemorrhage	1	1