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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device scale, stand-on, patient
Product CodeFRI
Regulation Number 880.2700
Device Class 1

MDR Year MDR Reports MDR Events
2014 2 2
2015 2 2
2018 1 1
2019 6 6
2020 3 3
2021 5 5
2022 3 3
2023 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Smoking 8 8
Temperature Problem 3 3
Inappropriate/Inadequate Shock/Stimulation 2 2
Device Displays Incorrect Message 2 2
Overheating of Device 2 2
Loss of Power 1 1
Failure to Power Up 1 1
Product Quality Problem 1 1
Break 1 1
Labelling, Instructions for Use or Training Problem 1 1
Incorrect Measurement 1 1
Melted 1 1
Device Emits Odor 1 1
Sparking 1 1
Calibration Problem 1 1
Detachment of Device or Device Component 1 1
Material Twisted/Bent 1 1
Power Problem 1 1
Protective Measures Problem 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 6 6
No Clinical Signs, Symptoms or Conditions 5 5
Insufficient Information 4 4
No Known Impact Or Consequence To Patient 2 2
Fall 2 2
Laceration(s) 1 1
Shock 1 1
Hip Fracture 1 1
Patient Problem/Medical Problem 1 1
No Information 1 1
Burn(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Scale Mfg Co II Jun-01-2017
2 Pelstar, Llc II Nov-28-2011
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