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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device retainer, surgical
Product CodeGCZ
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2018 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Break 6 6
Material Separation 6 6
Adverse Event Without Identified Device or Use Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 6 6
Not Applicable 2 2
No Information 2 2
Wound Dehiscence 2 2
Fistula 1 1
Incontinence 1 1
Sepsis 1 1

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