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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
2019 37 37
2020 51 51
2021 88 88
2022 64 64
2023 83 83
2024 24 24

Device Problems MDRs with this Device Problem Events in those MDRs
Break 158 158
Device-Device Incompatibility 69 69
Naturally Worn 35 35
Crack 31 31
Material Deformation 20 20
Material Twisted/Bent 18 18
Structural Problem 10 10
Mechanical Jam 9 9
Scratched Material 9 9
Contamination /Decontamination Problem 8 8
Detachment of Device or Device Component 7 7
Fracture 7 7
Entrapment of Device 6 6
Material Too Rigid or Stiff 4 4
Appropriate Term/Code Not Available 4 4
Difficult to Open or Close 3 3
Device Slipped 3 3
Component Missing 3 3
Difficult to Insert 3 3
Mechanical Problem 2 2
Material Fragmentation 2 2
Failure to Align 2 2
Material Integrity Problem 2 2
Physical Resistance/Sticking 2 2
Unintended Movement 2 2
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Split, Cut or Torn 1 1
Device Dislodged or Dislocated 1 1
Connection Problem 1 1
Use of Device Problem 1 1
Fitting Problem 1 1
Material Frayed 1 1
Off-Label Use 1 1
Positioning Failure 1 1
Device Reprocessing Problem 1 1
Corroded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 244 244
No Consequences Or Impact To Patient 69 69
Insufficient Information 13 13
Foreign Body In Patient 10 10
No Code Available 8 8
No Patient Involvement 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
No Known Impact Or Consequence To Patient 2 2

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