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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device degreaser, skin, surgical
Product CodeKOY
Regulation Number 878.4730
Device Class 1

MDR Year MDR Reports MDR Events
2019 2 2
2020 6 6
2021 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Nonstandard Device 5 5
Use of Device Problem 2 2
Microbial Contamination of Device 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burning Sensation 3 3
No Known Impact Or Consequence To Patient 3 3
Hair Loss 2 2
Hemorrhage/Bleeding 1 1
Irritation 1 1
Rash 1 1
Thrombosis/Thrombus 1 1
Insufficient Information 1 1
Burn(s) 1 1
Diarrhea 1 1
Tingling 1 1
Depression 1 1
Fungal Infection 1 1
Skin Tears 1 1
Hematuria 1 1
No Patient Involvement 1 1
Dysuria 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bio-Signal Group Corp. II Dec-18-2019
2 Carroll-Baccari, Inc. II Mar-20-2020
3 Carroll-Baccari, Inc. II Nov-13-2019
4 Neuronetrix Solutions, LLC dba Cognision II Dec-12-2019
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