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TPLC
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show TPLC since
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Device
bed, therapeutic, ac-powered, adjustable home-use
Product Code
LLI
Regulation Number
880.5100
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
95
95
2020
16
16
2021
3
3
2022
11
11
2023
20
20
2024
7
7
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
76
76
Appropriate Term/Code Not Available
11
11
Temperature Problem
11
11
Adverse Event Without Identified Device or Use Problem
8
8
Fire
5
5
Electrical /Electronic Property Problem
4
4
Improper or Incorrect Procedure or Method
4
4
Unintended Movement
4
4
Insufficient Information
4
4
Thermal Decomposition of Device
3
3
Break
2
2
Material Puncture/Hole
2
2
Device Slipped
2
2
Smoking
2
2
Material Integrity Problem
2
2
Material Protrusion/Extrusion
1
1
Mechanical Jam
1
1
Positioning Problem
1
1
Human-Device Interface Problem
1
1
Installation-Related Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Deformation
1
1
Activation Failure
1
1
Patient Device Interaction Problem
1
1
Component Misassembled
1
1
Explosion
1
1
Sharp Edges
1
1
Device Fell
1
1
Separation Problem
1
1
Misassembled During Installation
1
1
Use of Device Problem
1
1
Inadequacy of Device Shape and/or Size
1
1
Material Perforation
1
1
Sparking
1
1
Patient-Device Incompatibility
1
1
Component or Accessory Incompatibility
1
1
Collapse
1
1
Mechanical Problem
1
1
Melted
1
1
Device Emits Odor
1
1
No Device Output
1
1
Overheating of Device
1
1
No Apparent Adverse Event
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
74
74
Fall
26
26
No Clinical Signs, Symptoms or Conditions
17
17
No Known Impact Or Consequence To Patient
11
11
Laceration(s)
10
10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
7
7
Hematoma
4
4
Burn(s)
3
3
Bone Fracture(s)
2
2
Injury
2
2
Electric Shock
2
2
Swelling
2
2
No Patient Involvement
1
1
Pressure Sores
1
1
Physical Entrapment
1
1
Missing Value Reason
1
1
Cough
1
1
Unspecified Respiratory Problem
1
1
Multiple Fractures
1
1
Death
1
1
Eye Injury
1
1
Abrasion
1
1
Pain
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Craftmatic Industries, Inc.
II
Aug-04-2022
2
Invacare Corporation
II
Mar-04-2024
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