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TPLC
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show TPLC since
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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
2016
17
17
2017
8
8
2018
11
11
2019
13
13
2020
9
9
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
11
11
Adverse Event Without Identified Device or Use Problem
9
9
Detachment of Device or Device Component
8
8
Use of Device Problem
5
5
Unintended Movement
5
5
Device Operates Differently Than Expected
4
4
Device Tipped Over
3
3
Defective Component
2
2
Improper or Incorrect Procedure or Method
2
2
Collapse
2
2
Caster
2
2
Disconnection
2
2
Fracture
2
2
Loose or Intermittent Connection
2
2
Mechanical Problem
2
2
Device Fell
2
2
Unintended System Motion
1
1
Device Slipped
1
1
Device Inoperable
1
1
Unstable
1
1
Material Fragmentation
1
1
Lock
1
1
Loss of or Failure to Bond
1
1
Detachment Of Device Component
1
1
Crack
1
1
Screw
1
1
Belt
1
1
Bolt
1
1
Brake
1
1
Fitting Problem
1
1
Device-Device Incompatibility
1
1
Expulsion
1
1
Human Factors Issue
1
1
Material Protrusion/Extrusion
1
1
Device Subassembly
1
1
Locking Mechanism
1
1
Wheel
1
1
Wheelchair, Wheels
1
1
Insufficient Information
1
1
Patient Device Interaction Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Fall
21
21
Bone Fracture(s)
13
13
Laceration(s)
8
8
Injury
8
8
Head Injury
4
4
Bruise/Contusion
4
4
No Known Impact Or Consequence To Patient
4
4
No Consequences Or Impact To Patient
3
3
Cellulitis
2
2
Hemorrhage/Bleeding
2
2
Pain
2
2
No Information
2
2
No Code Available
1
1
Tooth Fracture
1
1
Vomiting
1
1
Weakness
1
1
Brain Injury
1
1
Death
1
1
Hip Fracture
1
1
Neck Pain
1
1
Abrasion
1
1
Sprain
1
1
Swelling
1
1
Concussion
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
R82 A/S
II
May-11-2019
2
R82 A/S
II
Nov-09-2018
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