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 Code	OOK
Regulation Number	878.4340
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	9232	9232
No Apparent Adverse Event	245	245
Insufficient Information	207	207
Leak/Splash	127	127
Patient-Device Incompatibility	26	26
Fluid/Blood Leak	14	14
Off-Label Use	12	12
Use of Device Problem	12	12
Therapeutic or Diagnostic Output Failure	9	9
Device Displays Incorrect Message	8	8
Sparking	6	6
Unintended Application Program Shut Down	5	5
Smoking	4	4
Improper or Incorrect Procedure or Method	4	4
Unexpected Therapeutic Results	4	4
Material Frayed	3	3
Device Handling Problem	3	3
Noise, Audible	3	3
Application Program Problem	3	3
Temperature Problem	3	3
Unexpected Shutdown	2	2
Crack	2	2
Output Problem	2	2
Material Integrity Problem	1	1
Insufficient Cooling	1	1
Inadequate or Insufficient Training	1	1
Nonstandard Device	1	1
Defective Component	1	1
No Audible Prompt/Feedback	1	1
Patient Device Interaction Problem	1	1
Degraded	1	1
Radiofrequency Interference (RFI)	1	1
Fungus in Device Environment	1	1
Infusion or Flow Problem	1	1
Appropriate Term/Code Not Available	1	1
Fire	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Device Emits Odor	1	1
Filling Problem	1	1
Detachment of Device or Device Component	1	1
Mechanical Problem	1	1
Break	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hyperplasia	9241	9241
No Clinical Signs, Symptoms or Conditions	189	189
Insufficient Information	109	109
Hernia	80	80
Pain	44	44
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	43	43
Deformity/ Disfigurement	30	30
Swelling/ Edema	17	17
Full thickness (Third Degree) Burn	15	15
Necrosis	15	15
Skin Discoloration	15	15
Physical Asymmetry	14	14
Partial thickness (Second Degree) Burn	12	12
Unspecified Tissue Injury	10	10
Nerve Damage	9	9
Inflammation	9	9
Numbness	8	8
Syncope/Fainting	7	7
Scar Tissue	7	7
Hematoma	7	7
Neuropathy	7	7
Pulmonary Hypertension	5	5
Depression	5	5
Emotional Changes	5	5
Anxiety	5	5
High Blood Pressure/ Hypertension	5	5
Dizziness	5	5
Swelling	4	4
Abdominal Distention	4	4
Neuralgia	4	4
Urticaria	3	3
Tingling	3	3
Erythema	3	3
Thrombosis	3	3
Itching Sensation	3	3
Abdominal Pain	3	3
Hematuria	3	3
Burn(s)	3	3
Weight Changes	3	3
Blister	2	2
Dyspnea	2	2
Subcutaneous Nodule	2	2
Thrombosis/Thrombus	2	2
Fibrosis	2	2
Pallor	2	2
Rupture	2	2
Embolism	2	2
Unspecified Respiratory Problem	2	2
Discomfort	2	2
Superficial (First Degree) Burn	2	2