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	40	40
Decrease in Suction	2	2
Off-Label Use	1	1
Patient-Device Incompatibility	1	1
Patient Device Interaction Problem	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Seroma	27	27
Deformity/ Disfigurement	10	10
Hematoma	5	5
Local Reaction	5	5
Scar Tissue	5	5
Skin Discoloration	4	4
Pain	4	4
Bruise/Contusion	4	4
Laceration(s)	3	3
Swelling/ Edema	3	3
Unspecified Infection	2	2
Impaired Healing	2	2
Necrosis	2	2
Cellulitis	2	2
Hemorrhage/Bleeding	2	2
Subcutaneous Nodule	2	2
Distress	2	2
Hypersensitivity/Allergic reaction	1	1
Localized Skin Lesion	1	1
Unspecified Nervous System Problem	1	1
Needle Stick/Puncture	1	1
Depression	1	1
Numbness	1	1
Suicidal Ideation	1	1
Insufficient Information	1	1
Ecchymosis	1	1
Abscess	1	1
Nodule	1	1
Pressure Sores	1	1
Fibrosis	1	1
Hyperemia	1	1