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TPLC
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show TPLC since
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2014
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2019
2020
2021
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2024
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Device
orthosis, corrective shoe
Product Code
KNP
Regulation Number
890.3475
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
4
4
2015
6
6
2016
3
3
2017
7
7
2018
3
3
2019
20
20
2020
6
6
2021
3
3
2022
8
8
2023
1
1
2024
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
25
25
Insufficient Information
15
15
Patient Device Interaction Problem
5
5
Break
4
4
Naturally Worn
3
3
Device Contaminated During Manufacture or Shipping
2
2
Product Quality Problem
2
2
Mechanical Problem
1
1
Device Markings/Labelling Problem
1
1
Material Twisted/Bent
1
1
Material Distortion
1
1
Use of Device Problem
1
1
Sharp Edges
1
1
Structural Problem
1
1
Loose or Intermittent Connection
1
1
Device Operates Differently Than Expected
1
1
Unstable
1
1
Device Slipped
1
1
Inflation Problem
1
1
Inadequacy of Device Shape and/or Size
1
1
Device Inoperable
1
1
Hole In Material
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pressure Sores
12
12
Ulcer
8
8
Unspecified Infection
6
6
Bone Fracture(s)
5
5
Injury
5
5
Pain
4
4
Fall
4
4
Unspecified Tissue Injury
3
3
Neuropathy
2
2
No Code Available
2
2
Head Injury
2
2
Therapeutic Response, Decreased
2
2
Post Traumatic Wound Infection
2
2
No Known Impact Or Consequence To Patient
2
2
Infection, Direct
1
1
Tissue Breakdown
1
1
Inadequate Pain Relief
1
1
Headache
1
1
Erosion
1
1
Tissue Damage
1
1
Myocardial Infarction
1
1
Muscle/Tendon Damage
1
1
Limb Fracture
1
1
Physical Entrapment
1
1
Laceration(s)
1
1
Insufficient Information
1
1
Skin Inflammation
1
1
Discomfort
1
1
Concussion
1
1
Swelling
1
1
Erythema
1
1
Thrombosis/Thrombus
1
1
Burn(s)
1
1
Post Operative Wound Infection
1
1
Neurological Deficit/Dysfunction
1
1
Rupture
1
1
Abrasion
1
1
No Information
1
1
Sprain
1
1
Joint Disorder
1
1
Sleep Dysfunction
1
1
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