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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument for treatment of hyperhidrosis
Definition Soft-tissue coagulation
Product CodeOUB
Regulation Number 878.4400
Device Class 2

MDR Year MDR Reports MDR Events
2019 96 96
2020 39 39
2021 12 12
2022 41 41
2023 49 49
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 219 219
Insufficient Information 18 18
Improper or Incorrect Procedure or Method 3 3
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 43 43
Neuropathy 28 28
Burn(s) 22 22
Numbness 20 20
Cyst(s) 17 17
Unspecified Infection 17 17
Pain 15 15
Swelling 11 11
Ulceration 11 11
Necrosis 11 11
Cellulitis 10 10
Skin Infection 9 9
Full thickness (Third Degree) Burn 7 7
Erythema 6 6
Inflammation 6 6
Skin Erosion 6 6
Fluid Discharge 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Partial thickness (Second Degree) Burn 4 4
Blister 4 4
Irritation 4 4
Nerve Damage 4 4
Tingling 3 3
Localized Skin Lesion 3 3
No Code Available 3 3
Swelling/ Edema 3 3
Subcutaneous Nodule 3 3
Skin Inflammation/ Irritation 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Post Operative Wound Infection 2 2
Ulcer 2 2
Scar Tissue 2 2
Fever 2 2
Itching Sensation 2 2
Edema 2 2
Breast Cancer 2 2
Bacterial Infection 2 2
Bruise/Contusion 2 2
Cardiac Arrest 1 1
Purulent Discharge 1 1
Laceration(s) 1 1
Muscle Weakness 1 1
Hematoma 1 1
Seroma 1 1
Skin Irritation 1 1
Phlebitis 1 1
Loss of Range of Motion 1 1
Malaise 1 1
Swollen Lymph Nodes 1 1
Thrombosis 1 1
Tissue Damage 1 1
Electric Shock 1 1
Vascular System (Circulation), Impaired 1 1
Limited Mobility Of The Implanted Joint 1 1
Decreased Sensitivity 1 1
Skin Inflammation 1 1
Sweating 1 1
Convulsion/Seizure 1 1
Thrombosis/Thrombus 1 1
Unspecified Reproductive System or Breast Problem 1 1
Skin Disorders 1 1
Fibrosis 1 1
Nodule 1 1

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