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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, transfer, patient, manual
Product CodeFMR
Regulation Number 880.6785
Device Class 1

MDR Year MDR Reports MDR Events
2014 4 4
2015 4 4
2016 6 6
2017 2 2
2018 8 8
2019 15 15
2020 2 2
2021 8 8
2022 6 6
2023 10 10
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Off-Label Use 8 8
Break 7 7
Inflation Problem 7 7
Use of Device Problem 6 6
Device Slipped 5 5
Device Operates Differently Than Expected 5 5
Material Split, Cut or Torn 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Improper or Incorrect Procedure or Method 3 3
Detachment of Device or Device Component 3 3
Unintended Movement 3 3
Unintended Deflation 2 2
Mechanical Problem 2 2
Structural Problem 2 2
Noise, Audible 2 2
Deflation Problem 2 2
Sparking 2 2
Fluid/Blood Leak 1 1
Component Falling 1 1
Inadequate User Interface 1 1
Fail-Safe Problem 1 1
Protective Measures Problem 1 1
Mechanics Altered 1 1
Fracture 1 1
Device Handling Problem 1 1
Device Dislodged or Dislocated 1 1
Material Rupture 1 1
Component Missing 1 1
Patient Device Interaction Problem 1 1
Fire 1 1
Physical Resistance/Sticking 1 1
Peeled/Delaminated 1 1
Torn Material 1 1
Unintended Electrical Shock 1 1
Material Integrity Problem 1 1
Device Fell 1 1
Positioning Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Disconnection 1 1
Installation-Related Problem 1 1
Electrical /Electronic Property Problem 1 1
Arcing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13 13
Injury 13 13
Fall 12 12
No Known Impact Or Consequence To Patient 11 11
Rash 8 8
Bone Fracture(s) 6 6
Pain 6 6
Hip Fracture 2 2
No Information 2 2
Head Injury 2 2
Numbness 2 2
No Consequences Or Impact To Patient 2 2
Patient Problem/Medical Problem 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Complaint, Ill-Defined 1 1
Electric Shock 1 1
Joint Dislocation 1 1
No Code Available 1 1
Unspecified Musculoskeletal problem 1 1
Hematoma 1 1
Insufficient Information 1 1
Loss of Range of Motion 1 1
Laceration(s) 1 1
Swelling/ Edema 1 1
Skin Tears 1 1
Pressure Sores 1 1
Hemorrhage/Bleeding 1 1

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