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TPLC
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show TPLC since
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2014
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2019
2020
2021
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2024
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Device
exerciser, powered
Product Code
BXB
Regulation Number
890.5380
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
5
5
2015
6
6
2016
6
6
2017
4
4
2018
2
2
2019
2
2
2021
2
2
2023
15
15
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
4
4
Use of Device Problem
4
4
Mechanics Altered
4
4
Break
4
4
Adverse Event Without Identified Device or Use Problem
3
3
Physical Resistance/Sticking
3
3
Sparking
2
2
Failure to Power Up
2
2
Detachment Of Device Component
2
2
Failure to Shut Off
1
1
Device Fell
1
1
Labelling, Instructions for Use or Training Problem
1
1
Detachment of Device or Device Component
1
1
Calibration Error
1
1
Material Separation
1
1
Protective Measures Problem
1
1
Complete Loss of Power
1
1
Nonstandard Device
1
1
Mechanical Problem
1
1
Fire
1
1
Failure to Auto Stop
1
1
Therapeutic or Diagnostic Output Failure
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Scratched Material
1
1
Device Inoperable
1
1
Loss of Power
1
1
Improper or Incorrect Procedure or Method
1
1
Loose or Intermittent Connection
1
1
Temperature Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
12
12
Bone Fracture(s)
6
6
Injury
4
4
Laceration(s)
4
4
No Known Impact Or Consequence To Patient
3
3
Insufficient Information
3
3
Swelling
2
2
Pain
2
2
Fall
2
2
Skin Tears
2
2
Hemorrhage/Bleeding
2
2
Bruise/Contusion
2
2
Emotional Changes
1
1
Disability
1
1
Hematoma
1
1
Perforation
1
1
Head Injury
1
1
Respiratory Acidosis
1
1
Burn(s)
1
1
No Patient Involvement
1
1
Physical Entrapment
1
1
Shock
1
1
Unspecified Tissue Injury
1
1
No Consequences Or Impact To Patient
1
1
Headache
1
1
Ambulation Difficulties
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Btt Health Gmbh
II
Sep-17-2024
2
MOTEK MEDICAL B.V.
II
May-27-2020
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