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TPLC
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show TPLC since
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Device
device, transfer, patient, manual
Product Code
FMR
Regulation Number
880.6785
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
15
15
2020
2
2
2021
8
8
2022
6
6
2023
10
10
2024
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Inflation Problem
6
6
Use of Device Problem
6
6
Device Slipped
5
5
Break
5
5
Material Split, Cut or Torn
4
4
Off-Label Use
4
4
Detachment of Device or Device Component
3
3
Deflation Problem
2
2
Improper or Incorrect Procedure or Method
2
2
Noise, Audible
2
2
Unintended Deflation
2
2
Structural Problem
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Sparking
1
1
Disconnection
1
1
Patient Device Interaction Problem
1
1
Material Rupture
1
1
Protective Measures Problem
1
1
Electrical /Electronic Property Problem
1
1
Inadequate User Interface
1
1
Physical Resistance/Sticking
1
1
Fire
1
1
Unintended Electrical Shock
1
1
Unintended Movement
1
1
Device Fell
1
1
Mechanics Altered
1
1
Tear, Rip or Hole in Device Packaging
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
13
13
Fall
8
8
Injury
5
5
Bone Fracture(s)
4
4
No Known Impact Or Consequence To Patient
4
4
Rash
4
4
Pain
4
4
Head Injury
2
2
Numbness
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Joint Dislocation
1
1
Electric Shock
1
1
Unspecified Musculoskeletal problem
1
1
Hematoma
1
1
Loss of Range of Motion
1
1
Insufficient Information
1
1
Laceration(s)
1
1
Swelling/ Edema
1
1
Skin Tears
1
1
Hemorrhage/Bleeding
1
1
No Consequences Or Impact To Patient
1
1
Pressure Sores
1
1
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