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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device accessories, wheelchair
Product CodeKNO
Regulation Number 890.3910
Device Class 1

MDR Year MDR Reports MDR Events
2014 2 2
2015 4 4
2016 2 2
2018 3 3
2021 2 2
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Device Operates Differently Than Expected 2 2
Physical Property Issue 1 1
Protective Measures Problem 1 1
Unintended Movement 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Fail-Safe Design Failure 1 1
Material Frayed 1 1
Structural Problem 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
Injury 2 2
Bone Fracture(s) 2 2
Head Injury 2 2
Hematoma 1 1
Laceration(s) 1 1
Damage to Ligament(s) 1 1
Blurred Vision 1 1
Visual Impairment 1 1
Pressure Sores 1 1
Skin Tears 1 1
No Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Fall 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Merits Holdings Co. dba Merits Health Products, Inc. II Apr-01-2020
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