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TPLC
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show TPLC since
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Device
instrument, compression
Product Code
HWN
Regulation Number
888.4540
Device Class
1
MDR Year
MDR Reports
MDR Events
2018
21
21
2019
37
37
2020
51
51
2021
88
88
2022
64
64
2023
78
78
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
152
152
Device-Device Incompatibility
59
59
Crack
30
30
Naturally Worn
28
28
Material Twisted/Bent
18
18
Material Deformation
13
13
Mechanical Jam
10
10
Structural Problem
9
9
Entrapment of Device
6
6
Fracture
6
6
Scratched Material
6
6
Contamination /Decontamination Problem
6
6
Detachment of Device or Device Component
6
6
Appropriate Term/Code Not Available
5
5
Component Missing
4
4
Material Too Rigid or Stiff
4
4
Device Slipped
3
3
Difficult to Insert
3
3
Difficult to Open or Close
3
3
Material Integrity Problem
2
2
Unintended Movement
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Mechanical Problem
2
2
Fitting Problem
2
2
Failure to Align
2
2
Material Fragmentation
2
2
Material Split, Cut or Torn
2
2
Physical Resistance/Sticking
2
2
Material Frayed
1
1
Positioning Failure
1
1
Device Reprocessing Problem
1
1
Corroded
1
1
Sparking
1
1
Off-Label Use
1
1
Use of Device Problem
1
1
No Apparent Adverse Event
1
1
Insufficient Information
1
1
Therapeutic or Diagnostic Output Failure
1
1
Connection Problem
1
1
Device Dislodged or Dislocated
1
1
Flare or Flash
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
220
220
No Consequences Or Impact To Patient
81
81
No Patient Involvement
10
10
Foreign Body In Patient
9
9
No Code Available
9
9
Insufficient Information
8
8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
No Known Impact Or Consequence To Patient
3
3
No Information
2
2
Unspecified Infection
1
1
Not Applicable
1
1
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