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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bandage, cast
Product CodeITG
Regulation Number 890.3025
Device Class 1

MDR Year MDR Reports MDR Events
2019 4 4
2020 3 3
2021 5 5
2022 9 9
2023 3 3
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Material Too Soft/Flexible 7 7
Adverse Event Without Identified Device or Use Problem 5 5
Insufficient Information 3 3
Appropriate Term/Code Not Available 2 2
Break 1 1
Crack 1 1
Mechanical Problem 1 1
Unsealed Device Packaging 1 1
Self-Activation or Keying 1 1
Device Slipped 1 1
Failure to Obtain Sample 1 1
Patient-Device Incompatibility 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7 7
Injury 4 4
Partial thickness (Second Degree) Burn 3 3
Blister 2 2
Skin Infection 2 2
Skin Inflammation/ Irritation 2 2
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Skin Disorders 1 1
Skin Tears 1 1
Fluid Discharge 1 1
Full thickness (Third Degree) Burn 1 1
No Information 1 1
No Code Available 1 1
Muscle/Tendon Damage 1 1
Congenital Defect/Deformity 1 1
Unspecified Infection 1 1
Pain 1 1
Rash 1 1
Swelling 1 1
No Consequences Or Impact To Patient 1 1

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