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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device marker, skin
Product CodeFZZ
Regulation Number 878.4660
Device Class 1

MDR Year MDR Reports MDR Events
2019 18 18
2020 14 14
2021 12 12
2022 1 1
2023 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Unsealed Device Packaging 15 15
Defective Component 10 10
Adverse Event Without Identified Device or Use Problem 10 10
Defective Device 9 9
Detachment of Device or Device Component 2 2
Off-Label Use 2 2
Material Separation 1 1
Use of Device Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Packaging Problem 1 1
Unintended Movement 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 17 17
No Known Impact Or Consequence To Patient 12 12
Unspecified Infection 7 7
Abscess 6 6
No Consequences Or Impact To Patient 5 5
No Patient Involvement 5 5
Inflammation 3 3
Necrosis 3 3
Insufficient Information 2 2
Bacterial Infection 1 1
Dysphagia/ Odynophagia 1 1
Edema 1 1

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