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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
2019 15 15
2020 2 2
2021 8 8
2022 6 6
2023 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Inflation Problem 6 6
Device Slipped 5 5
Use of Device Problem 5 5
Break 5 5
Off-Label Use 4 4
Material Split, Cut or Torn 4 4
Detachment of Device or Device Component 3 3
Structural Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Noise, Audible 2 2
Deflation Problem 2 2
Unintended Deflation 2 2
Physical Resistance/Sticking 1 1
Device Fell 1 1
Unintended Electrical Shock 1 1
Disconnection 1 1
Fire 1 1
Material Rupture 1 1
Improper or Incorrect Procedure or Method 1 1
Patient Device Interaction Problem 1 1
Protective Measures Problem 1 1
Unintended Movement 1 1
Sparking 1 1
Mechanics Altered 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12 12
Fall 7 7
Injury 5 5
No Known Impact Or Consequence To Patient 4 4
Rash 4 4
Pain 3 3
Bone Fracture(s) 3 3
Head Injury 2 2
Hematoma 1 1
Loss of Range of Motion 1 1
No Consequences Or Impact To Patient 1 1
Pressure Sores 1 1
Unspecified Musculoskeletal problem 1 1
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Joint Dislocation 1 1
Numbness 1 1
Electric Shock 1 1

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