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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device chair, examination and treatment
Product CodeFRK
Regulation Number 880.6140
Device Class 1

MDR Year MDR Reports MDR Events
2019 7 9
2020 8 12
2021 4 4
2022 1 1
2023 5 8
2024 2 3

Device Problems MDRs with this Device Problem Events in those MDRs
Device Fell 7 13
Sharp Edges 5 7
Adverse Event Without Identified Device or Use Problem 4 4
Unintended Movement 2 3
No Fail-Safe Mechanism 2 2
Unintended System Motion 2 2
Device Slipped 2 2
Device Tipped Over 1 1
Detachment of Device or Device Component 1 2
Defective Alarm 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13 21
Fall 4 4
No Consequences Or Impact To Patient 3 5
No Patient Involvement 3 4
Laceration(s) 2 2
Insufficient Information 2 2
Pain 2 2
Crushing Injury 1 1
Skin Tears 1 1
Hemorrhage/Bleeding 1 1
Bone Fracture(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Medical Division of Stryker Corporation II Aug-06-2021
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