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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tape, measuring, rulers and calipers
Product CodeFTY
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 11 11
2020 112 112
2021 161 161
2022 93 93
2023 9 9
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Break 327 327
Fracture 22 22
Crack 16 16
Naturally Worn 14 14
Material Twisted/Bent 6 6
Component Missing 5 5
Labelling, Instructions for Use or Training Problem 4 4
Detachment of Device or Device Component 4 4
Material Fragmentation 4 4
Material Separation 3 3
Material Deformation 3 3
Mechanical Jam 2 2
Scratched Material 2 2
Mechanics Altered 1 1
Device Damaged Prior to Use 1 1
Device Markings/Labelling Problem 1 1
Defective Device 1 1
Unintended Movement 1 1
No Apparent Adverse Event 1 1
Difficult to Open or Close 1 1
Deformation Due to Compressive Stress 1 1
Connection Problem 1 1
Misassembled 1 1
Product Quality Problem 1 1
Corroded 1 1
Material Integrity Problem 1 1
Device Fell 1 1
Solder Joint Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 297 297
No Patient Involvement 38 38
No Known Impact Or Consequence To Patient 32 32
No Consequences Or Impact To Patient 24 24
Insufficient Information 6 6
No Information 4 4

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