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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cutaneous electrode stimulator for urinary incontinence
Definition A transcutaneous electrical continence device consists of cutaneous electrodes that are used to apply external stimulation to reduce urinary incontinence.
Product CodeQAJ
Regulation Number 876.5330
Device Class 2


Premarket Reviews
ManufacturerDecision
ATLANTIC THERAPEUTICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
ELIDAH INC
  SUBSTANTIALLY EQUIVALENT 1
ELIDAH, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2022 6 6
2023 5 5
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 6 6
Stretched 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Unexpected Therapeutic Results 1 1
Defective Component 1 1
Energy Output Problem 1 1
Product Quality Problem 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 9 9
Dizziness 2 2
Pain 2 2
Shock from Patient Lead(s) 2 2
Syncope/Fainting 1 1
Neuralgia 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Transient Ischemic Attack 1 1
Twitching 1 1
Arrhythmia 1 1
Erythema 1 1
Numbness 1 1

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