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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device kit, catheter, urinary (exludes hiv testing)
Definition Urinary Catheterization Kit (Excludes HIV Testing)
Product CodeNWO
Regulation Number 876.5130
Device Class 2

MDR Year MDR Reports MDR Events
2014 1 1
2017 2 2
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1 1
Deflation Problem 1 1
Use of Device Problem 1 1
Device Operates Differently Than Expected 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 1 1
No Known Impact Or Consequence To Patient 1 1
Not Applicable 1 1
No Information 1 1
Kidney Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Customed, Inc II Apr-14-2016
2 Customed, Inc II Sep-03-2015
3 Customed, Inc I Dec-16-2014
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