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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device patient personal hygiene kit
Definition This device contains items given to an individual during their hospital stay.
Product CodeNSB
Regulation Number 872.6855
Device Class 1

MDR Year MDR Reports MDR Events
2014 1 1
2015 1 1
2018 1 1
2019 1 1
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 2 2
Leak/Splash 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Detachment of Device or Device Component 1 1
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 2 2
Hemorrhage/Bleeding 2 2
Skin Irritation 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
2 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
3 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
4 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
5 MEDLINE INDUSTRIES, LP - Northfield I Dec-22-2023
6 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
7 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
8 Sage Products Inc II Aug-02-2019
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