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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 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Break 305 305
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
Physical Resistance/Sticking 11 11
Material Deformation 10 10
Insufficient Information 7 7
Material Integrity Problem 7 7
Firing Problem 6 6
Material Fragmentation 6 6
Device Dislodged or Dislocated 5 5
Failure to Advance 5 5
Misassembled 5 5
Material Split, Cut or Torn 5 5
Delivered as Unsterile Product 4 4
No Apparent Adverse Event 4 4
Ejection Problem 4 4
Device Fell 3 3
Entrapment of Device 3 3
Failure to Fire 3 3
Nonstandard Device 3 3
Device-Device Incompatibility 3 3
Device Damaged Prior to Use 3 3
Failure to Cycle 2 2
Difficult to Open or Remove Packaging Material 2 2
Difficult to Insert 2 2
Activation Problem 2 2
Separation Problem 2 2
Difficult to Open or Close 2 2
Solder Joint Fracture 1 1
Misfire 1 1
Separation Failure 1 1
Use of Device Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Loose or Intermittent Connection 1 1
Difficult to Remove 1 1
Defective Device 1 1
Unintended Movement 1 1
Grounding Malfunction 1 1
Inaccurate Information 1 1
Appropriate Term/Code Not Available 1 1
Product Quality Problem 1 1
Flaked 1 1
Expiration Date Error 1 1
Retraction Problem 1 1
Difficult to Fold, Unfold or Collapse 1 1
Crack 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 329 329
No Known Impact Or Consequence To Patient 131 131
No Consequences Or Impact To Patient 29 29
Foreign Body In Patient 23 23
No Information 14 14
No Patient Involvement 9 9
Insufficient Information 7 7
Injury 5 5
Device Embedded In Tissue or Plaque 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Hypersensitivity/Allergic reaction 2 2
Failure of Implant 1 1
No Code Available 1 1
Scar Tissue 1 1
Chills 1 1
Rupture 1 1
Loss of Range of Motion 1 1
Pain 1 1
Unspecified Infection 1 1

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