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TPLC
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show TPLC since
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Device
chair, with casters
Product Code
INM
Regulation Number
890.3100
Device Class
1
MDR Year
MDR Reports
MDR Events
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
Misassembly by Users
16
16
Break
15
15
Adverse Event Without Identified Device or Use Problem
11
11
Detachment of Device or Device Component
9
9
Use of Device Problem
8
8
Unintended Movement
6
6
Device Fell
5
5
Device Operates Differently Than Expected
4
4
Collapse
4
4
Device Tipped Over
3
3
Insufficient Information
3
3
Misassembled During Installation
2
2
Defective Component
2
2
Improper or Incorrect Procedure or Method
2
2
Disconnection
2
2
Fracture
2
2
Loose or Intermittent Connection
2
2
Mechanical Problem
2
2
Unintended System Motion
2
2
Device Slipped
2
2
Device Inoperable
1
1
Unstable
1
1
Detachment Of Device Component
1
1
Crack
1
1
Material Fragmentation
1
1
Fitting Problem
1
1
Loss of or Failure to Bond
1
1
Connection Problem
1
1
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
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Fall
44
44
Head Injury
15
15
Bone Fracture(s)
14
14
No Clinical Signs, Symptoms or Conditions
13
15
Laceration(s)
9
9
Bruise/Contusion
8
8
Injury
8
8
No Known Impact Or Consequence To Patient
5
5
Insufficient Information
4
4
No Consequences Or Impact To Patient
3
3
Pain
3
3
Cellulitis
2
2
Hemorrhage/Bleeding
2
2
Abrasion
2
2
Concussion
2
2
Brain Injury
2
2
No Information
2
2
No Code Available
1
1
Hydrocephalus
1
1
Unspecified Tissue Injury
1
1
Unspecified Infection
1
1
Hip Fracture
1
1
Tooth Fracture
1
1
Neck Pain
1
1
Death
1
1
Sprain
1
1
Swelling
1
1
Vomiting
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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