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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
52
52
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
131
131
Device-Device Incompatibility
58
58
Crack
28
28
Naturally Worn
25
25
Material Twisted/Bent
18
18
Material Deformation
13
13
Mechanical Jam
11
11
Structural Problem
10
10
Contamination /Decontamination Problem
6
6
Detachment of Device or Device Component
6
6
Scratched Material
5
5
Appropriate Term/Code Not Available
5
5
Entrapment of Device
5
5
Fracture
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
Material Split, Cut or Torn
2
2
Physical Resistance/Sticking
2
2
Unintended Movement
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Mechanical Problem
2
2
Fitting Problem
2
2
Material Fragmentation
2
2
Material Frayed
1
1
Positioning Failure
1
1
Device Reprocessing Problem
1
1
Corroded
1
1
Failure to Align
1
1
Sparking
1
1
Off-Label Use
1
1
Use of Device Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
No Apparent Adverse Event
1
1
Flare or Flash
1
1
Connection Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
195
195
No Consequences Or Impact To Patient
81
81
No Patient Involvement
10
10
No Code Available
9
9
Foreign Body In Patient
8
8
Insufficient Information
7
7
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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