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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 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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