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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device passer
Product CodeHWQ
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2019 55 55
2020 171 171
2021 160 160
2022 63 63
2023 60 60
2024 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Break 298 298
Material Separation 54 54
Detachment of Device or Device Component 35 35
Mechanical Jam 25 25
Mechanical Problem 17 17
Fracture 12 12
Adverse Event Without Identified Device or Use Problem 12 12
Material Deformation 10 10
Physical Resistance/Sticking 10 10
Material Integrity Problem 7 7
Insufficient Information 7 7
Firing Problem 6 6
Material Split, Cut or Torn 5 5
Device Dislodged or Dislocated 5 5
Material Fragmentation 5 5
Failure to Advance 5 5
Misassembled 5 5
Delivered as Unsterile Product 4 4
Ejection Problem 4 4
No Apparent Adverse Event 4 4
Device Fell 3 3
Failure to Fire 3 3
Entrapment of Device 3 3
Nonstandard Device 3 3
Device Damaged Prior to Use 3 3
Device-Device Incompatibility 3 3
Difficult to Open or Close 2 2
Difficult to Open or Remove Packaging Material 2 2
Failure to Cycle 2 2
Difficult to Insert 2 2
Activation Problem 2 2
Separation Problem 2 2
Inaccurate Information 1 1
Material Twisted/Bent 1 1
Migration 1 1
Unintended Movement 1 1
Loose or Intermittent Connection 1 1
Melted 1 1
Unsealed Device Packaging 1 1
Product Quality Problem 1 1
Difficult to Remove 1 1
Retraction Problem 1 1
Positioning Failure 1 1
Crack 1 1
Flaked 1 1
Difficult to Fold, Unfold or Collapse 1 1
Grounding Malfunction 1 1
Expiration Date Error 1 1
Misfire 1 1
Separation Failure 1 1
Defective Device 1 1
Solder Joint Fracture 1 1
Problem with Sterilization 1 1
Unstable 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 322 322
No Known Impact Or Consequence To Patient 131 131
No Consequences Or Impact To Patient 29 29
Foreign Body In Patient 19 19
No Information 14 14
No Patient Involvement 9 9
Insufficient Information 7 7
Device Embedded In Tissue or Plaque 5 5
Injury 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Hypersensitivity/Allergic reaction 2 2
Failure of Implant 1 1
Unspecified Infection 1 1
Pain 1 1
Loss of Range of Motion 1 1
Scar Tissue 1 1
Chills 1 1
Rupture 1 1
No Code Available 1 1

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