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TPLC
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Device
chair, with casters
Regulation Description
Mechanical chair.
Product Code
INM
Regulation Number
890.3100
Device Class
1
MDR Year
MDR Reports
MDR Events
2021
22
22
2022
11
13
2023
11
12
2024
8
8
2025
15
15
Device Problems
MDRs with this Device Problem
Events in those MDRs
Misassembly by Users
16
16
Use of Device Problem
8
9
Break
7
7
Adverse Event Without Identified Device or Use Problem
7
7
Insufficient Information
4
4
Device Fell
3
3
Device Slipped
2
2
Collapse
2
2
Unintended Movement
2
2
Misassembled During Installation
2
2
Device Tipped Over
1
1
Sharp Edges
1
3
Misassembly During Maintenance/Repair
1
1
Detachment of Device or Device Component
1
1
Device Dislodged or Dislocated
1
1
Appropriate Term/Code Not Available
1
2
Unintended System Motion
1
1
Connection Problem
1
1
Human-Device Interface Problem
1
1
Naturally Worn
1
1
Improper or Incorrect Procedure or Method
1
1
Loss of or Failure to Bond
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Fall
29
29
No Clinical Signs, Symptoms or Conditions
16
18
Head Injury
11
11
Bone Fracture(s)
8
8
Bruise/Contusion
8
8
Insufficient Information
5
6
Laceration(s)
3
3
Pain
2
2
Unspecified Infection
1
1
Joint Dislocation
1
1
Brain Injury
1
1
Abrasion
1
1
Rash
1
1
Concussion
1
1
Eye Injury
1
1
Hydrocephalus
1
1
Unspecified Tissue Injury
1
1
Swelling/ Edema
1
1
Hemorrhage/Bleeding
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Accora Inc
II
Sep-13-2021
2
Ki Mobility Llc
III
Jan-07-2022
3
Sunrise Medical (US) LLC
II
Jul-28-2021
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