TPLC - Total Product Life Cycle

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Device	powered surgical instrument for improvement in the appearance of cellulite
Regulation Description	Powered surgical instrument for improvement in the appearance of cellulite.
Definition	Used for controlled release of subcutaneous tissue for improvement in the appearance of cellulite.
Product Code	OUP
Regulation Number	878.4790
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	38	38
Decrease in Suction	2	2
Break	1	1
Off-Label Use	1	1
Patient-Device Incompatibility	1	1
Insufficient Information	1	1
Patient Device Interaction Problem	1	1
Failure to Cut	1	1
No Apparent Adverse Event	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Seroma	24	24
Deformity/ Disfigurement	10	10
Scar Tissue	6	6
Hematoma	5	5
Local Reaction	5	5
Pain	5	5
Bruise/Contusion	5	5
Skin Discoloration	4	4
Laceration(s)	4	4
Swelling/ Edema	3	3
Impaired Healing	2	2
Unspecified Infection	2	2
Necrosis	2	2
No Known Impact Or Consequence To Patient	2	2
Cellulitis	2	2
Hemorrhage/Bleeding	2	2
Subcutaneous Nodule	2	2
Distress	2	2
Hypersensitivity/Allergic reaction	1	1
Scarring	1	1
Blood Loss	1	1
Localized Skin Lesion	1	1
Unspecified Nervous System Problem	1	1
Needle Stick/Puncture	1	1
Depression	1	1
Suicidal Ideation	1	1
Numbness	1	1
Insufficient Information	1	1
Ecchymosis	1	1
Abscess	1	1
Anxiety	1	1
Nodule	1	1
Pressure Sores	1	1
Fibrosis	1	1
Hyperemia	1	1