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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device crutch
Product CodeIPR
Regulation Number 890.3150
Device Class 1

MDR Year MDR Reports MDR Events
2014 53 53
2015 12 12
2016 9 9
2017 4 4
2018 4 4
2019 4 4
2020 5 5
2021 3 3
2022 4 4
2023 7 7
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 42 42
Unstable 10 10
Collapse 5 5
Product Quality Problem 5 5
Detachment Of Device Component 5 5
Device Slipped 3 3
Material Disintegration 3 3
Disassembly 3 3
Bent 3 3
Fracture 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Loose or Intermittent Connection 3 3
Device Fell 2 2
Detachment of Device or Device Component 2 2
Torn Material 2 2
Crack 2 2
Split 2 2
Material Integrity Problem 2 2
Appropriate Term/Code Not Available 2 2
Device Operates Differently Than Expected 2 2
Naturally Worn 2 2
Material Frayed 1 1
Material Split, Cut or Torn 1 1
Insufficient Information 1 1
Material Separation 1 1
Component Falling 1 1
Defective Device 1 1
Defective Component 1 1
Material Deformation 1 1
Degraded 1 1
Material Twisted/Bent 1 1
Out-Of-Box Failure 1 1
Device Issue 1 1
Deformation Due to Compressive Stress 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 40 40
Fall 29 29
Injury 12 12
No Clinical Signs, Symptoms or Conditions 5 5
Discomfort 4 4
Laceration(s) 4 4
Bone Fracture(s) 3 3
Damage to Ligament(s) 2 2
No Known Impact Or Consequence To Patient 2 2
Insufficient Information 2 2
Pain 2 2
Skin Tears 2 2
Sleep Dysfunction 1 1
No Code Available 1 1
Disability 1 1
Head Injury 1 1
Abrasion 1 1
Contusion 1 1
No Patient Involvement 1 1
Muscle/Tendon Damage 1 1
Unspecified Tissue Injury 1 1
Loss of consciousness 1 1

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