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TPLC
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Device
accessories, wheelchair
Product Code
KNO
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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