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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
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Device
gauge, depth
Regulation Description
Depth gauge for clinical use.
Product Code
HTJ
Regulation Number
888.4300
Device Class
1
MDR Year
MDR Reports
MDR Events
2021
403
404
2022
316
318
2023
376
377
2024
371
371
2025
407
408
2026
38
38
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
1026
1027
Material Deformation
552
556
Mechanical Jam
105
105
Device-Device Incompatibility
89
89
Incorrect Measurement
57
57
Use of Device Problem
42
42
Fracture
36
37
Detachment of Device or Device Component
26
26
Material Integrity Problem
24
24
Illegible Information
22
22
Naturally Worn
21
21
Mechanical Problem
20
20
Device Slipped
14
14
Material Discolored
14
14
Material Twisted/Bent
13
13
No Apparent Adverse Event
11
11
Corroded
8
8
Entrapment of Device
8
8
Crack
7
7
Appropriate Term/Code Not Available
6
6
Defective Device
5
5
Tear, Rip or Hole in Device Packaging
4
4
Degraded
4
4
Failure to Cut
4
4
Adverse Event Without Identified Device or Use Problem
3
3
Contamination /Decontamination Problem
3
3
Device Damaged Prior to Use
3
3
Device Markings/Labelling Problem
2
2
Physical Resistance/Sticking
2
2
Component Missing
1
1
Material Fragmentation
1
1
Scratched Material
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Misassembled
1
1
Difficult to Remove
1
1
Failure to Clean Adequately
1
1
Material Separation
1
1
Unintended Movement
1
1
Device Dislodged or Dislocated
1
1
Output Problem
1
1
Fitting Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Disconnection
1
1
Noise, Audible
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1796
1801
Insufficient Information
107
107
Foreign Body In Patient
9
9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Pneumothorax
1
1
Failure of Implant
1
1
Laceration(s)
1
1
Unspecified Tissue Injury
1
1
Hemorrhage/Bleeding
1
1
Bacterial Infection
1
1
Device Embedded In Tissue or Plaque
1
1
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