TPLC - Total Product Life Cycle

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Device	instrument for treatment of hyperhidrosis
Regulation Description	Electrosurgical cutting and coagulation device and accessories.
Definition	Soft-tissue coagulation
Product Code	OUB
Regulation Number	878.4400
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	155	155
Insufficient Device Problem Information	20	20
Improper or Incorrect Procedure or Method	12	12
No Apparent Adverse Event	2	2
Increase in Pressure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Burn(s)	37	37
Abscess	33	33
Skin Infection	20	20
Numbness	18	18
Swelling/ Edema	15	15
Skin Erosion	8	8
Full thickness (Third Degree) Burn	7	7
Nerve Damage	7	7
Skin Inflammation/ Irritation	6	6
Neuropathy	6	6
Blister	5	5
Localized Skin Lesion	4	4
Hematoma	4	4
Partial thickness (Second Degree) Burn	4	4
Necrosis	4	4
Pain	4	4
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	4	4
Cyst(s)	3	3
Subcutaneous Nodule	3	3
Cellulitis	3	3
Fluid Discharge	2	2
Ulcer	2	2
Unspecified Infection	2	2
No Clinical Signs, Symptoms or Conditions	2	2
Bruise/Contusion	1	1
Inflammation	1	1
Erythema	1	1
Post Operative Wound Infection	1	1
Unspecified Reproductive System or Breast Problem	1	1
Convulsion/Seizure	1	1
Purulent Discharge	1	1
Contact Dermatitis	1	1
Bacterial Infection	1	1
Thrombosis/Thrombus	1	1
Skin Irritation	1	1
Scar Tissue	1	1
Skin Disorders	1	1
Muscle Weakness/Atrophy	1	1
Cardiac Arrest	1	1
High Blood Pressure/ Hypertension	1	1
Nodule	1	1
Itching Sensation	1	1