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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device binder, abdominal
Product CodeFSD
Regulation Number 880.5160
Device Class 1

MDR Year MDR Reports MDR Events
2014 14 14
2015 3 3
2016 2 2
2018 2 2
2023 15 15
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 16 16
Adverse Event Without Identified Device or Use Problem 8 8
Insufficient Information 5 5
Patient-Device Incompatibility 4 4
Device Contamination with Chemical or Other Material 1 1
Material Distortion 1 1
Material Integrity Problem 1 1
Appropriate Term/Code Not Available 1 1
Material Frayed 1 1
Stretched 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Rash 32 32
Itching Sensation 3 3
Erythema 2 2
Reaction 2 2
Skin Irritation 2 2
Wheal(s) 1 1
Discomfort 1 1
Missing Value Reason 1 1

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