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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
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
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
17
17
Misassembly by Users
16
16
Use of Device Problem
13
13
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
5
5
Device Operates Differently Than Expected
4
4
Improper or Incorrect Procedure or Method
4
4
Device Slipped
4
4
Collapse
4
4
Device Tipped Over
3
3
Device Inoperable
3
3
Fracture
2
2
Unintended System Motion
2
2
Loose or Intermittent Connection
2
2
Detachment Of Device Component
2
2
Disconnection
2
2
Mechanical Problem
2
2
Defective Component
2
2
Misassembled During Installation
2
2
Appropriate Term/Code Not Available
1
1
Device Dislodged or Dislocated
1
1
Connection Problem
1
1
Human-Device Interface Problem
1
1
Loss of or Failure to Bond
1
1
Device-Device Incompatibility
1
1
Unstable
1
1
Fitting Problem
1
1
Expulsion
1
1
Split
1
1
Crack
1
1
Material Fragmentation
1
1
Human Factors Issue
1
1
Patient Device Interaction Problem
1
1
Sharp Edges
1
3
Misassembly During Maintenance/Repair
1
1
Material Protrusion/Extrusion
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Fall
48
48
Bone Fracture(s)
15
15
Head Injury
15
15
No Clinical Signs, Symptoms or Conditions
13
15
Injury
11
11
Laceration(s)
11
11
No Known Impact Or Consequence To Patient
10
10
Bruise/Contusion
9
9
Insufficient Information
4
4
Pain
4
4
No Consequences Or Impact To Patient
4
4
Concussion
3
3
Death
2
2
Hip Fracture
2
2
Brain Injury
2
2
No Information
2
2
Abrasion
2
2
Cellulitis
2
2
Swelling
2
2
Hemorrhage/Bleeding
2
2
Unspecified Infection
1
1
Joint Dislocation
1
1
No Code Available
1
1
Sprain
1
1
Tooth Fracture
1
1
Suture Abrasion
1
1
Weakness
1
1
Neck Pain
1
1
Vomiting
1
1
Visual Impairment
1
1
Hydrocephalus
1
1
Unspecified Tissue Injury
1
1
Skin Tears
1
1
Headache
1
1
Ambulation Difficulties
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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