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TPLC
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show TPLC since
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Device
exerciser, powered
Regulation Description
Powered exercise equipment.
Product Code
BXB
Regulation Number
890.5380
Device Class
1
MDR Year
MDR Reports
MDR Events
2016
6
6
2017
4
4
2018
2
2
2019
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
3
3
Handpiece
2
2
Break
2
2
Use of Device Problem
2
2
Improper or Incorrect Procedure or Method
1
1
Failure to Auto Stop
1
1
Mechanics Altered
1
1
Calibration Error
1
1
Detachment Of Device Component
1
1
Labelling, Instructions for Use or Training Problem
1
1
Loose or Intermittent Connection
1
1
Nonstandard Device
1
1
Device Inoperable
1
1
Device Fell
1
1
Protective Measures Problem
1
1
Temperature Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Injury
4
4
No Known Impact Or Consequence To Patient
3
3
Laceration(s)
2
2
Pain
1
1
Bruise/Contusion
1
1
Bone Fracture(s)
1
1
No Patient Involvement
1
1
Burn(s)
1
1
Swelling
1
1
Ambulation Difficulties
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
MOTEK MEDICAL B.V.
II
May-27-2020
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