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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
2014 2 2
2016 1 1
2017 4 4
2018 15 15
2019 4 4
2020 3 3
2021 5 5
2022 9 9
2023 3 3
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 10 10
Material Too Soft/Flexible 9 9
Adverse Event Without Identified Device or Use Problem 5 5
Insufficient Information 4 4
Appropriate Term/Code Not Available 3 3
Device Operates Differently Than Expected 2 2
Collapse 2 2
Crack 1 1
Mechanical Problem 1 1
Unsealed Device Packaging 1 1
Self-Activation or Keying 1 1
Device Slipped 1 1
Defective Component 1 1
Failure to Obtain Sample 1 1
Patient-Device Incompatibility 1 1
Environmental Particulates 1 1
Device Contamination with Chemical or Other Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Temperature Problem 1 1
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 12 12
No Clinical Signs, Symptoms or Conditions 7 7
Partial thickness (Second Degree) Burn 4 4
No Consequences Or Impact To Patient 4 4
Rash 3 3
No Known Impact Or Consequence To Patient 3 3
Skin Infection 2 2
Skin Inflammation/ Irritation 2 2
Unspecified Infection 2 2
No Information 2 2
Blister 2 2
Skin Disorders 1 1
No Code Available 1 1
Full thickness (Third Degree) Burn 1 1
Skin Tears 1 1
Fluid Discharge 1 1
Pain 1 1
Abrasion 1 1
Bruise/Contusion 1 1
Congenital Defect/Deformity 1 1
Swelling 1 1
Pressure Sores 1 1
Discomfort 1 1
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Sep-18-2013
2 Integra LifeSciences Corp. II Apr-24-2018
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