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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device chair, with casters
Product CodeINM
Regulation Number 890.3100
Device Class 1

MDR Year MDR Reports MDR Events
2015 15 15
2016 18 18
2017 8 8
2018 11 11
2019 13 13
2020 9 9
2021 22 22
2022 11 13
2023 11 11
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 17 17
Misassembly by Users 16 16
Use of Device Problem 12 12
Adverse Event Without Identified Device or Use Problem 11 11
Detachment of Device or Device Component 10 10
Unintended Movement 6 6
Device Fell 5 5
Insufficient Information 4 4
Device Operates Differently Than Expected 4 4
Improper or Incorrect Procedure or Method 4 4
Device Slipped 4 4
Collapse 4 4
Device Inoperable 3 3
Device Tipped Over 3 3
Defective Component 2 2
Detachment Of Device Component 2 2
Disconnection 2 2
Fracture 2 2
Loose or Intermittent Connection 2 2
Mechanical Problem 2 2
Unintended System Motion 2 2
Misassembled During Installation 2 2
Misassembly During Maintenance/Repair 1 1
Appropriate Term/Code Not Available 1 1
Patient Device Interaction Problem 1 1
Sharp Edges 1 3
Device-Device Incompatibility 1 1
Device Dislodged or Dislocated 1 1
Expulsion 1 1
Human Factors Issue 1 1
Human-Device Interface Problem 1 1
Material Protrusion/Extrusion 1 1
Material Fragmentation 1 1
Crack 1 1
Split 1 1
Connection Problem 1 1
Unstable 1 1
Fitting Problem 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 47 47
Head Injury 15 15
Bone Fracture(s) 15 15
No Clinical Signs, Symptoms or Conditions 13 15
Laceration(s) 11 11
Injury 11 11
No Known Impact Or Consequence To Patient 10 10
Bruise/Contusion 9 9
Pain 4 4
Insufficient Information 4 4
No Consequences Or Impact To Patient 4 4
Concussion 3 3
Hip Fracture 2 2
Death 2 2
Brain Injury 2 2
Cellulitis 2 2
Abrasion 2 2
Swelling 2 2
No Information 2 2
Hemorrhage/Bleeding 2 2
Skin Tears 1 1
Ambulation Difficulties 1 1
Sprain 1 1
Neck Pain 1 1
Headache 1 1
Suture Abrasion 1 1
Vomiting 1 1
Unspecified Infection 1 1
Visual Impairment 1 1
No Code Available 1 1
Hydrocephalus 1 1
Unspecified Tissue Injury 1 1
Tooth Fracture 1 1
Weakness 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Accora Inc II Sep-13-2021
2 Ki Mobility Llc III Jan-07-2022
3 R82 A/S II May-11-2019
4 R82 A/S II Nov-09-2018
5 Sunrise Medical (US) LLC II Jul-28-2021
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