TPLC - Total Product Life Cycle

• Device: instrument for treatment of hyperhidrosis
• Definition: Soft-tissue coagulation
• Product Code: OUB
• Regulation Number: 878.4400
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2018	131	131
2019	96	96
2020	39	39
2021	12	12
2022	41	41
2023	49	49
2024	20	20

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	349	349
Insufficient Information	28	28
Improper or Incorrect Procedure or Method	7	7
No Apparent Adverse Event	2	2
Patient-Device Incompatibility	1	1
Increase in Pressure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Abscess	81	81
Unspecified Infection	48	48
Neuropathy	42	42
Burn(s)	40	40
Ulceration	26	26
Pain	26	26
Cyst(s)	23	23
Numbness	23	23
Necrosis	19	19
Swelling	18	18
Cellulitis	15	15
Skin Infection	9	9
Full thickness (Third Degree) Burn	9	9
Partial thickness (Second Degree) Burn	9	9
Bacterial Infection	8	8
Scar Tissue	8	8
Erythema	7	7
Skin Erosion	7	7
Hematoma	6	6
Inflammation	6	6
Fluid Discharge	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Fibrosis	5	5
Edema	5	5
Nerve Damage	5	5
Blister	4	4
Irritation	4	4
Tingling	3	3
Subcutaneous Nodule	3	3
No Code Available	3	3
Swelling/ Edema	3	3
Localized Skin Lesion	3	3
Fever	3	3
Bruise/Contusion	2	2
Ulcer	2	2
Phlebitis	2	2
Skin Inflammation	2	2
Post Operative Wound Infection	2	2
Scarring	2	2
Itching Sensation	2	2
Purulent Discharge	2	2
Skin Inflammation/ Irritation	2	2
No Clinical Signs, Symptoms or Conditions	2	2
Breast Cancer	2	2
Sweating	2	2
Seroma	1	1
Rash	1	1
Thrombosis/Thrombus	1	1
Alteration In Body Temperature	1	1
Loss of Range of Motion	1	1