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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device instrument, compression
Product CodeHWN
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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